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 1301–1320 of 38,428 recalls
Recalled Item: Medical convenience kits IHDC30R D AND C PACK
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Basic Biopsy Tray
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Basic Biopsy Tray
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XERF EFFECTOR 60. Electrosurgical unit.
The Issue: Manufacturing defects in devices manufactured from 4/1/25 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item number/ Product description AKGN82E GENERAL...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon
The Issue: Carotid stent and post-dilation balloon system with integrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: issue that can cause the device to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The Issue: The FlexLab X System Sample Integrity Module (SIM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The Issue: The FlexLab System Sample Integrity Module (SIM) includes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNCHRON Systems Phosphorus (PHOSm) Reagent For In Vitro
The Issue: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.