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 18961–18980 of 38,428 recalls
Recalled Item: Proximal Humerus Plate
The Issue: Right Proximal Humerus Plates. Product component parts MDS130108R,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm FDR Go PLUS
The Issue: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH Urinary Drainage bag
The Issue: The device labels are not UDI compliant. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH CARE Premium Drain bag
The Issue: The device labels are not UDI compliant. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex Burr
The Issue: Devices may generate excessive heat during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHIMADZU MobileDaRt Evolution (MX8 Version)
The Issue: In these units, the brake is usually released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is
The Issue: Normal operation of the device is to power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRINIAS for diagnostic imaging and interventional procedures in cardiac...
The Issue: Two issues: Event 1: Normal operation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M(TM) Surgical Clipper by Remington(R) The 3M Surgical
The Issue: 3M has recently received reports involving the 3MTM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethyl Alcohol Enzymatic Assay
The Issue: Shelf life of the product may be reduced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: aap Implante AG
The Issue: There is the potential for the Lambotte chisel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 reagent cards: a) GN ID
The Issue: This notice has been initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management
The Issue: User-induced circumstances can contribute to the EVOLIS Microplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoDELFIA¿ hCG Kit
The Issue: hCG analyte concentrations may be decreased up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELFIA¿ hCG Kit
The Issue: hCG analyte concentrations may be decreased up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoDELFIA¿ hCG Kit
The Issue: hCG analyte concentrations may be decreased up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter
The Issue: The product lidstock contains a labelling error. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter
The Issue: The product lidstock contains a labelling error. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively
The Issue: Some of the installed valve-inserts have a diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.