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 23981–24000 of 38,428 recalls
Recalled Item: GE Healthcare Revolution EVO X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery NM/CT 670 CZT X-ray system
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CT660
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery PET/CT 600
The Issue: It was discovered that an issue has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTARAY NAV High-Density Mapping Catheter.
The Issue: Contraindication language updated in the Instructions For Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTARAY NAV High-Density Mapping Catheter.
The Issue: Contraindication language updated in the Instructions For Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuikClot TraumaPad
The Issue: Packaging breach may compromise sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KYPHON(R) Directional Bone Filler Device
The Issue: The directional arrow at the proximal end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vantage Total Ankle Tibial Insert
The Issue: inner labeling and packaged device not matching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vantage Total Ankle Tibial Insert
The Issue: inner labeling and packaged device not matching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 Gram Negative test kits containing colistin (cs01n)
The Issue: The investigation demonstrated a high rate of very
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe Systems with Software Version VD10B
The Issue: Software error. In Sensis Vibe systems with software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FFR Link-FFR Signal Processing Module
The Issue: The device history record (DHR) was missing its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Synchron AQUA CAL Level 1
The Issue: The firm identified a negative shift of 5mmol/L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Testosterone
The Issue: Complaints were received from customers observing falsely overestimate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06...
The Issue: for electric shock in the case of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD¿ High Volume Administration Set with FlowStop
The Issue: One lot of CADD¿ High Volume Administration sets,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tubing Pack Convenience Kit
The Issue: Kit was labeled with the incorrect Expiration Date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product
The Issue: Combo Screw Driver (Product Code 288211) tip has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product
The Issue: Combo Screw Driver (Product Code 288211) tip has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.