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 21321–21340 of 38,428 recalls
Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spring-Wire Guide Introducer Catheter Assembly
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit with Sharps Safety Features
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)...
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NvisionVLE¿ Low-Profile Optical Probe
The Issue: Distal tips of the probes may detach from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife M6
The Issue: There is an unintended drop of a secondary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife VSI
The Issue: There is an unintended drop of a secondary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium
The Issue: Bard Medical Division is recalling the BARD¿ BrachySource¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angio-Seal Evolution Vascular Closure Device
The Issue: Two lots of product were released for distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS FSH
The Issue: Invalid calibration with low calibrator S1 while using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLD Systems 600 Series Washer/Pasteurizer
The Issue: There is a supplier quality issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
The Issue: IFU contained an automated cleaning process for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING
The Issue: A single lot of GENESIS II FEMORAL FIVE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM
The Issue: There is a potential for improper welding of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM
The Issue: There is a potential for improper welding of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DriSate¿ Product Code DR-145 The acid concentrate powders and liquids
The Issue: A subassembly component (dextrose bag) within this case
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OviTex 1S Reinforced BioScaffold 4x8cm
The Issue: Degradation of the PGA suture material used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OviTex Reinforced BioScaffold 6x10cm
The Issue: Degradation of the PGA suture material used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OviTex 2S Reinforced BioScaffold 10x12cm
The Issue: Degradation of the PGA suture material used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OviTex 1S Reinforced BioScaffold 10x12cm
The Issue: Degradation of the PGA suture material used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.