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Last updated: Unknown
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 AlertType: 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.
View Full AlertType: Other | Date: 2025-10-31
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one.
View Full AlertType: Other | Date: 2025-10-31
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one.
View Full AlertType: 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 AlertType: 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 AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: Recall | Date: 2025-10-07
Tri Nvidia Health, Inc. is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters.
View Full AlertType: Recall | Date: 2025-10-07
Tri Nvidia Health, Inc. is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters.
View Full AlertType: Safety | Date: 2025-09-30
ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.
View Full AlertType: Safety | Date: 2025-09-30
ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.
View Full AlertType: Recall | Date: 2025-09-29
Medical device recalls can lead to product recall. What is a Medical Device Recall? What are the reasons for the recall? What is the product recall?
View Full AlertType: Recall | Date: 2025-09-29
Medical device recalls can lead to product recall. What is a Medical Device Recall? What are the reasons for the recall? What is the product recall?
View Full AlertType: Other | Date: 2025-09-29
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction.
View Full AlertType: 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 AlertType: 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 AlertType: Recall | Date: 2025-09-29
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
View Full AlertType: Recall | Date: 2025-09-29
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
View Full AlertType: Other | Date: 2025-09-24
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.
View Full AlertType: Other | Date: 2025-09-24
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.
View Full AlertType: Other | Date: 2025-09-23
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.
View Full AlertType: Other | Date: 2025-09-23
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues.
View Full AlertType: Other | Date: 2025-09-22
Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles. The action applies to needles manufactured prior to May 12, 2025.
View Full AlertType: Other | Date: 2025-09-22
Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles. The action applies to needles manufactured prior to May 12, 2025.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: 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.
View Full AlertType: Recall | Date: 2025-09-16
Medline is recalling certain Kits containing recalled Medtronic DLP Left Heart Vent Catheters. Catheter may not retain its shape.
View Full AlertType: Other | Date: 2025-09-16
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.
View Full AlertType: Other | Date: 2025-09-16
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.
View Full AlertType: 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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