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 6881–6900 of 38,428 recalls
Recalled Item: Para-Pak Clean Vial-For the collection
The Issue: Plastic vials contain a manufacturing defect may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit - For access to the subarachnoid
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial access kit (without Prep solutions) Bit and Guard-For
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip Modular Cooler-Heater
The Issue: There is a potential for the heating-chamber to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip Modular Cooler-Heater
The Issue: There is a potential for the heating-chamber to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit-For access to the subarachnoid space or
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Cranial Access Kit-For access to the subarachnoid space or
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit -For access to the subarachnoid space
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit-For access to the subarachnoid space or
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cranial Access Kit- For access to the subarachnoid space
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Cranial Access Kit-For access to the subarachnoid space or
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid
The Issue: Defect in the outer packaging of the Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 97745 Controller used with Models 97715 and 97716 Intellis
The Issue: Units distributed in Korea and Turkey that did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Platform 100-240V- 50/60Hz 1440w
The Issue: Their is the potential that software issues may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Platform
The Issue: Their is the potential that software issues may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Platform
The Issue: Their is the potential that software issues may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIKSTIK
The Issue: A complaint investigation showed that the bulk pellets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYFO-DISK
The Issue: A complaint investigation showed that the bulk pellets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SagiPlan 2.2
The Issue: Due to software malfunction, numerical values may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lugol s Iodine Solution 500ML
The Issue: Due to the incorrect packaging utilized with lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.