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 14921–14940 of 38,428 recalls
Recalled Item: Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis 6 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thora-Para 8 Fr Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
The Issue: The Universal Drainage Set (UDS) may contain valves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath Paediatric catheters for blind protected distal bronchial...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath catheters for blind or fibrescope-guided protected distal...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath Paediatric catheters for blind protected distal bronchial...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodimed Combicath catheters for blind or fibrescope-guided protected distal...
The Issue: Sterility Concerns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RP500e Handheld Barcode Scanner
The Issue: The scanner is not confirming the integrity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANAX 5.5 Poly-Reduction Screw 6.0X50MM
The Issue: 6.0x50mm poly-reduction screws were laser etched 6.0x45
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood gases (PCO2
The Issue: risk of patient mix-up on analyzers due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood gases (PCO2
The Issue: risk of patient mix-up on analyzers due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric Adjustable Flange Tracheostomy Tube Cuffless
The Issue: One lot of 3.0mm Bivona Cuffless Adjustable Neck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation standalone software treatment planning system (RayStation 8A
The Issue: It is not obvious that the manual import
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray System
The Issue: Two issues were identified with the computed tomography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
The Issue: Due to adverse events received by the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.