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 37201–37220 of 38,428 recalls
Recalled Item: Oxoid Antimicrobial Susceptibility Discs
The Issue: The firm is recalling the product because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs
The Issue: The firm is recalling the product due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm
The Issue: Vycor Medical recalled their VBAS (Vycor Viewsite Brain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed
The Issue: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON
The Issue: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra External Beam 4.1. Radiation treatment planning software designed to
The Issue: During the planning process the beam weights can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 45 3.5 mm Universal Straight Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray Systems
The Issue: A bolt which attaches the oil accumulator within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 60 3.5 mm Universal Straight Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 60 4.8 mm Universal Straight Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Duet TRS 45 4.8 mm Universal Straight Single Use
The Issue: Duet TRS may have the potential to injure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Mobilett Mira. Mobile X-Ray System.
The Issue: During regular product monitoring, Siemens has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Xpect Clostridium difficile Toxin A/B
The Issue: The firm is recalling the products due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Xpect Clostridium difficile Toxin A/B
The Issue: The firm is recalling the products due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO
The Issue: In house testing confirmed that CK-MS and Insulin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Armada 35/ Armada 35 LL PTA Catheters. The device is
The Issue: Abbott Vascular is recalling the Armada 35 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.