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 22121–22140 of 38,428 recalls
Recalled Item: ultraView SISH DNP Detection Kit US
The Issue: Increased reports of leaking and sticking reagent dispensers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CINtec PLUS Cytology Kit (CE-IVD)
The Issue: Increased reports of leaking and sticking reagent dispensers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiView Amplification Kit (250 Test)
The Issue: Increased reports of leaking and sticking reagent dispensers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiView DAB IHC Detection Kit
The Issue: Increased reports of leaking and sticking reagent dispensers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultraView SISH Detection Kit
The Issue: Increased reports of leaking and sticking reagent dispensers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Group Smart Perfusion Pack E-Pack
The Issue: The product is labeled with the incorrect expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable Cardioverter Defibrillators (ICDs)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable Cardioverter Defibrillators (ICDs)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable Cardioverter Defibrillators (ICDs)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable Cardioverter Defibrillators (ICDs)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
The Issue: prevention of high and low voltage therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray...
The Issue: DeRoyal manufactured custom sterile surgical kits containing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G.
The Issue: Package integrity failure observed during routine shift package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra)
The Issue: In certain scenarios the ADVIA Centaur CP, XP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur BNP (B-type Natriuretic Peptide)
The Issue: In certain scenarios the ADVIA Centaur CP, XP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿...
The Issue: blood leaks through the hydrophobic portion of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImmunoCAP Allergen c5
The Issue: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.