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 36241–36260 of 38,428 recalls
Recalled Item: VITEK 2 Compact computer system when equipped with the following
The Issue: There is a potential to link an isolate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Smart 150
The Issue: The leg spreading mechanism will fail to hoist
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Therapy Treatment Planning System
The Issue: Under some circumstances, imported CT, MR and PET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended
The Issue: Firm is recalling due to concerns regarding changes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Smart 150
The Issue: The leg spreading mechanism will fail to hoist
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX Micros IM2
The Issue: Horiba Medical is recalling ABX Micros IM2 Data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance
The Issue: This field change order is being released to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame
The Issue: The bed frame adapter assemblies may have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is
The Issue: Distribution of an unapproved device into interstate commerce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml
The Issue: The BD Vacutainer Urinalysis Transfer Straw Kit #364991,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellispace Portal (ISP) Philips Medical Systems (Cleveland)
The Issue: Philips was notified of a problem using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Immunoassay System
The Issue: Beckman Coulter is initiating a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Test Strips packaged in the OC-Light Manual iFOBT Kit
The Issue: The test strips in the affected product lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System
The Issue: Beckman Coulter is initiating a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Test Strips packaged in the OC-Light Manual iFOBT Kit
The Issue: The test strips in the affected product lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 600i Synchron Access Clinical System
The Issue: Beckman Coulter is initiating a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchron LXi 725 Clinical System
The Issue: Beckman Coulter is initiating a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization
The Issue: The control boards alarm set points and temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in
The Issue: Addendum to the Instructions for Use. The addendum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrapro Antipruritic Hydrogel
The Issue: Out of specification result - stability test failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.