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 10341–10360 of 38,428 recalls
Recalled Item: Various PICC Line
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaC UNO H [120V
The Issue: Internal ethernet cable may be misaligned, the cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nordicBrainEX
The Issue: When exporting merged results from the BOLD, DSC,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaC UNO H [120V
The Issue: Internal ethernet cable may be misaligned, the cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARS CoV 2 rapid antigen test kits packaged under the
The Issue: Various brands of SARS CoV 2 Antigen Rapid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiCount+ System Application
The Issue: When scanning sponges out after a surgical procedure,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis with software version VD12A. A diagnostic and administrative tool
The Issue: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe Combo with software version VD12A. A diagnostic and
The Issue: Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS Software Version 7.0 SP0.0.4.7
The Issue: The Event Notification Manager (ENM) functionality for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sight OLO
The Issue: The default reference ranges for MCH, MCHC, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative
The Issue: The Instructions for Use (IFU, Part Number 750095)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wright EVOLVE TRIAD Plate Cutter
The Issue: The plate cutter is unable to meet sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeGlobal Fast Freeze Thawing Kit
The Issue: There was translation error in the Spanish version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yukon Straight Rod 4.0 x120mm
The Issue: Some of the rods in this lot were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1
The Issue: Complaints received in which needle and needle holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G
The Issue: Complaints received in which needle and needle holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Platinum 5NXG Oxygen Concentrator
The Issue: Between March 2, 2021 and December 31, 2021,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Pheno
The Issue: A video signal from one of the transceivers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 11B
The Issue: This notice concerns two issues found related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for falsely elevated Hemoglobin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.