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 37881–37900 of 38,428 recalls
Recalled Item: GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pudenz Flushing Valve with Integral Connectors
The Issue: The pouch label of catalog NL850-1330 indicates an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unicel DxH 800 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the UniCel DxH 800
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip
The Issue: The lyophilized thrombin component of the Surgiflo Hemostatic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland...
The Issue: Stryker Orthopaedics has become aware of a burr,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Four Birthing Bed P3700 Product Usage: The Affinity
The Issue: During review of our last braking system via
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vacuette Quickshield Complete Plus
The Issue: : The Quickshield Complete Plus may have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with
The Issue: Product was packaged with the incorrect port and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 324JL On-Board Suction System Intended use: On-board suction system
The Issue: A shipment mix-up took place
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-15SB - 1.5MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-15SD - 1.5MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-1SD - 1MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Micro Curved Attachment (MCA) Cutting Burr
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-15SD - 1.5MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA5-15SB - 1.5MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-06SD - 0.6MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-2SB - 2MM Fluted Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach MCA Cutting Burr
The Issue: Current directions for use for the MCA cutting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-07SD - 0.7MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MCA7-1SD - 1MM Diamond Ball
The Issue: The Anspach Effort, Inc. is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.