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 28221–28240 of 38,428 recalls
Recalled Item: Gender PFJ FEMORAL COMP
The Issue: LDPE bag containing the implant adheres to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eclipse Treatment Planning System versions 11
The Issue: When using PBC 11.0.31 to calculate the dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic
The Issue: Blade exhibiting fracture during hip arthroscopy procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Uric Acid CP ref. A11A01670 is an in
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ABX PENTRA Cholesterol CP ref. A11A01634 is an in
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended
The Issue: N-Acetylcysteine (NAC) present in the blood of patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
The Issue: NatalCare LX Incubators were manufactured using a defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization
The Issue: Product potentially exposed to body fluids during processing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended
The Issue: There is a possibility that the device may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be
The Issue: Increased punch height, causing a 0.063 in (1.6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This...
The Issue: Olympus America Inc is conducting a voluntary removal/corrective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0
The Issue: In DS/US proton planning, there is a correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API ZYM Bx2 () Product Usage: ZYM B reagent
The Issue: Discrepant identification results related to API identification strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System: HeartWare Battery
The Issue: Heartware Ventricular Assist System Battery Cell experiencing premature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.