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Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Type: Other | Date: 2026-02-03

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

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Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Type: Other | Date: 2026-01-15

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors. Some sensors may provide incorrect low glucose readings.

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Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Type: Other | Date: 2026-01-15

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors. Some sensors may provide incorrect low glucose readings.

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Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Type: Other | Date: 2026-01-15

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors. Some sensors may provide incorrect low glucose readings.

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Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

Type: Other | Date: 2026-01-15

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors. Some sensors may provide incorrect low glucose readings.

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Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Type: Recall | Date: 2026-01-09

123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for

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Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Type: Recall | Date: 2026-01-09

123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for

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Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Type: Recall | Date: 2026-01-09

123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods

Type: Recall | Date: 2025-12-26

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.

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Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels

Type: Recall | Date: 2025-12-22

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. The product has been found to contain lead at levels

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Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels

Type: Recall | Date: 2025-12-22

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. The product has been found to contain lead at levels

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Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels

Type: Recall | Date: 2025-12-22

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. The product has been found to contain lead at levels

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Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels

Type: Recall | Date: 2025-12-22

Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. The product has been found to contain lead at levels

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Type: Approval | Date: 2025-12-19

FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa. Based on available data, the serious risks including the increase in thromBoembolic.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

Type: Recall | Date: 2025-12-16

StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Type: Other | Date: 2025-11-21

Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

Type: Recall | Date: 2025-11-03

Otsuka ICU Medical LLC is issuing a voluntary recall to the user level. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

View Full Alert

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

View Full Alert

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Type: Other | Date: 2025-10-15

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices. FDA asks for reports of injuries related to these devices.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

Type: Other | Date: 2025-10-10

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

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What is an Early Alert?

Type: Other | Date: 2025-09-29

Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction.

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What is an Early Alert?

Type: Other | Date: 2025-09-29

Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction.

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Recall and Alert Resources

Type: Recall | Date: 2025-09-29

This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices.

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Recall and Alert Resources

Type: Recall | Date: 2025-09-29

This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices.

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Recall and Alert Resources

Type: Recall | Date: 2025-09-29

This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices.

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Recall and Alert Resources

Type: Recall | Date: 2025-09-29

This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices.

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Recall and Alert Resources

Type: Recall | Date: 2025-09-29

This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices.

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Type: Other | Date: 2025-09-23

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Type: Other | Date: 2025-09-23

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Type: Other | Date: 2025-09-23

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Type: Other | Date: 2025-09-23

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Type: Other | Date: 2025-09-23

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Type: Other | Date: 2025-09-18

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues.

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Type: Other | Date: 2025-09-18

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues.

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Type: Other | Date: 2025-09-18

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues.

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Type: Other | Date: 2025-09-18

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues.

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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Type: Other | Date: 2025-09-18

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues.

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Type: Safety | Date: 2025-09-17

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware.

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Type: Safety | Date: 2025-09-17

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware.

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Type: Safety | Date: 2025-09-17

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware.

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Type: Safety | Date: 2025-09-17

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware.

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Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

Type: Safety | Date: 2025-09-16

FDA alerts of risks with use of unauthorized infant monitoring devices. The devices have not been reviewed for safety and effectiveness.

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Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication

Type: Safety | Date: 2025-09-16

FDA alerts of’risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.

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Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure

Type: Other | Date: 2025-09-15

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail. This could cause missed alerts and delayed treatment of hypo/hyperglycemia.

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This tool is for informational purposes only and does not provide medical advice.

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