Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 11641–11660 of 38,428 recalls
Recalled Item: The MEDRAD Twist & Go Disposable Syringe 150 mL with
The Issue: Labeling error: MEDRAD Mark 7 Arterion Injection System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Monaco - Product Usage: used to make treatment plans
The Issue: Contour changes can be saved on an unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Bio-Medicus Insertion Kits
The Issue: There was a label mix-up between two model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCH Leg Positioning System
The Issue: Due to the holes not being bored to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIVE S 3.5x65
The Issue: During a regular requalification review, affected flexible intubation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foundation Kit
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IUD Insertion Pack
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IUD Insertion Kit
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Easi-Care Gait Belt Metal Buckle (54"
The Issue: The belt may fail at lower loads than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tenaculum
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endometrial Biopsy Kit
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Standard IUD Insertion Kit
The Issue: Firm unable to confirm that the tenaculum devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls...
The Issue: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outsi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the
The Issue: Software 2.51 and Lower with Installed CO2 Measurement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX)
The Issue: The Firmware (FW) of the Automation System Interface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the
The Issue: Software 2.51 and Lower with Installed CO2 Measurement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoHelical and TomoDirect plans in RayStation 6
The Issue: If the dynamic jaw mode is used and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C315-HIS Delivery Catheter
The Issue: Medtronic is recalling three lots of unused C315HIS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee
The Issue: Packaging may include screws that are not intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENOSYL DS (Delivery System) console
The Issue: Manufacturing defect involving reversal of the inlet and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.