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 32221–32240 of 38,428 recalls
Recalled Item: Pilling Knife Handles: a) b) c)
The Issue: The knife handles slot depth is out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Saturated Gauze Dressing Wound management
The Issue: Formulation deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Post-op Surgical Kits Wound management
The Issue: Formulation deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Hydrogel Wound Dressing Wound management
The Issue: Formulation deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Daily Dressing Packets Wound management
The Issue: Formulation deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Calibrator E
The Issue: Positive bias for Calibrator E lot kits ending
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Maestro Microcatheter
The Issue: These microcatheters were packaged with a 2.8 F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freedom EVO-2 100 Base Unit
The Issue: Distortion (noise interference) of the liquid level capacitance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set
The Issue: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments
The Issue: An investigation identified that high level friction may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments
The Issue: An investigation identified that high level friction may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments
The Issue: An investigation identified that high level friction may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COMPASS
The Issue: Error in the software. A deviation between reconstructed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Spirit Combo insulin infusion pump sold as part of
The Issue: The insulin pump may lose time and date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equate Moisture Last Multi-Purpose Solution
The Issue: Product lot did not meet the specification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
The Issue: Loss of key image functionality due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Switches used with the following systems: Philips Allura Xper Systems
The Issue: Loss of key image functionality due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Bone Level Implant 04.1 mm RC
The Issue: Product transfer piece was fitted with a Narrow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used
The Issue: Internal testing has confirmed a low absorbance range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed
The Issue: The Easy-Care Care-Lock feature installed at the foot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.