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 19161–19180 of 38,428 recalls
Recalled Item: "J" Type Bone Marrow Needle 11ga x 10 cm -
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Diamond J Type Bone Marrow Needle & Marrow Extraction
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERMA-HAND Silk Suture Size 5
The Issue: The sutures inside the packaging are not the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate Gen.2
The Issue: New endogenous interference claims have been established for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bilirubin Total Gen.3
The Issue: New endogenous interference claims have been established for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tina-quant IgM Gen.2
The Issue: New endogenous interference claims have been established for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are
The Issue: The adhesive used in the repair of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended
The Issue: The adhesive used in the repair of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These...
The Issue: The adhesive used in the repair of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These...
The Issue: The adhesive used in the repair of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anti-HAV IgM test System
The Issue: for erroneous result messages for the Anti-HAV
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter
The Issue: Stryker s Sustainability Solutions division (SSS) has received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREMIER Cryptococcal Antigen
The Issue: An enzyme reagent included in the kit is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal(R) Enteral Safe Feed Tube
The Issue: Enteral Safe Feeding Tubes labeled as 6.5 FR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBAS INTEGRA 400 plus analyzer used in the following assays:
The Issue: COBAS INTEGRA¿ 400 plus and cobas c 111
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas c 111 with ISE analyzers analyzer used in the
The Issue: COBAS INTEGRA¿ 400 plus and cobas c 111
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter
The Issue: Incorrect (higher) Rated Burst Pressure information printed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draco Enzymatic Deep-Cleaning Pads
The Issue: The product is contaminated with Pseudomonas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.