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 32301–32320 of 38,428 recalls
Recalled Item: ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro
The Issue: Increased imprecision and positive bias is observed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Expression Information Portal (IP5) Model 865471. The IP5 is
The Issue: Frozen Display Numerics and Disabled Menu Keys after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nordicICE 2.3.14 Image processing software package used by trained professionals
The Issue: An error was discovered in the interpretation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP
The Issue: Stability of the ADVIA Centaur Cleaning Solution is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prescription eyeglass safety lenses. Vision correction
The Issue: Prescription eyeglass safety lenses did not meet specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omni Micro-electrode/ electrode for cobas b221 analyzer. The Roche Diagnostics
The Issue: The default references for normal values are inconsistent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human lgG4 Subclass kit for use on the Beckman Coulter
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human lgG4 Subclass Liquid Reagent Kits For use on the
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human lgG4 Subclass Liquid Reagent Kits for use on the
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human lgG Subclass Liquid Reagent Kits for use on the
The Issue: Customer complaints identified that samples containing extremely high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1
The Issue: 17% of ARCHITECT Total T3 Reagent Kit, LN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Ingenuity CT
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASSEMBLY
The Issue: Correction due to the detection of a motor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Labeled in part: I Color Complete / Color Lens
The Issue: A surveillance sample collected by FDA confirmed the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Labeled in part: I Color Complete / Crazy Lens
The Issue: A surveillance sample collected by FDA confirmed the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System 2.5 mm Female Screw 48
The Issue: The Persona 48mm X 2.5mm Female Screw is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran MiniCAT X-ray imaging device
The Issue: Out of tolerance kVp, Unexposed (black) frames, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.