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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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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

Type: Recall | Date: 2025-11-20

Convenience Kits labeled as sterile but not having gone through sterilization process. Medline is recalling certain Convenience kits due to being labeled as sterilized.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

Type: Other | Date: 2025-11-19

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System.

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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.

View Full Alert

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.

View Full Alert

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.

View Full Alert

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.

View Full Alert

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

Type: Other | Date: 2025-11-03

Olympus Corporation has announced a voluntary, global medical device corrective action. The action aims to provide further clarification on the safe and effective use of bronchoscopes.

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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.

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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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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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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Type: Other | Date: 2025-10-10

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.

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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.

View Full Alert

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.

View Full Alert

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.

View Full Alert

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.

View Full Alert

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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Powered by real-time FDA RSS feeds and enhanced with local LLM summarization and classification.

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

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