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 37261–37280 of 38,428 recalls
Recalled Item: Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description:...
The Issue: Applied Medical is recalling specific lot numbers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Embolectomy Catheters (Models A44XX
The Issue: Applied Medical is recalling specific lot numbers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW
The Issue: T-handle screw is used on a complementary product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra CRW Precision Arc (CRWPRECISE)
The Issue: T-handle screw is used on a complementary product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnilife Science Apex Knee System Modular Tibia Augment
The Issue: The Apex Knee System Modular Tibia Augment may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory
The Issue: There is potential for the sterility of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AmeriWater MRO Dialysis RO+ System
The Issue: The firm was notified that a malfunction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3DKnee e+ Tibial Insert - HXLPE-VE
The Issue: The firm is recalling one lot of 392-09-706,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and
The Issue: Loss of patient data can occur under certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoPulse Resuscitation System Model 100
The Issue: Complaints associated with an unexpected stop in AutoPulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Devices includes a Multi Port Inflator or without Multi Port
The Issue: Parks Medical Electronics, Inc. was made aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Positron Emission Tomography (PET) and X-ray Computed Tomography
The Issue: Philips became aware of an issue relating to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare conducted a recall on various mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number.
The Issue: ADVIA Centaur Prolactin Assay and FSH, Calibrator B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator
The Issue: ADVIA Centaur Prolactin Assay and FSH, Calibrator B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.