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 22801–22820 of 38,428 recalls
Recalled Item: VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
The Issue: This product is not meeting the current storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
The Issue: This product is not meeting the current storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
The Issue: This product is not meeting the current storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015)
The Issue: Product was placed into distribution prior to completion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary...
The Issue: The device is used as part of extracorporeal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Better-Bladder cardiopulmonary bypass blood reservoir
The Issue: The device is used as part of extracorporeal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MAX-CORE Disposable Core Biopsy Instrument
The Issue: During the review of May 2017 complaint data,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: proSA Tool Set used to adjust and verify the proSA
The Issue: A proSA adjusting pin used to adjust the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric...
The Issue: Reports of gastric or esophageal perforation occurring in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Ascenda(R) Intrathecal Catheter
The Issue: There is a possibility that specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Dialysis Kit CF-4235 Without Gel
The Issue: 2 Cuff catheters were incorrectly configured and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled
The Issue: 2 Cuff catheters were incorrectly configured and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Dialysis Kit CF-4230 Without Gel
The Issue: 1 Cuff catheters were incorrectly configured and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used
The Issue: Some SureSigns VSi, VS2+ products have the Date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: daVinci X EndoWrist(R) Stapler 45
The Issue: Specific da Vinci Xi EndoWrist Stapler 45 instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Constrained Condylar Offset Screw
The Issue: There is a design incompatibility between certain sizes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Constrained Condylar Offset Screw
The Issue: There is a design incompatibility between certain sizes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Constrained Condylar Offset Screw
The Issue: There is a design incompatibility between certain sizes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Offset Tibial Tray and Screws
The Issue: There is a design incompatibility between certain sizes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Constrained Condylar Offset Screw
The Issue: There is a design incompatibility between certain sizes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.