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 12421–12440 of 38,428 recalls
Recalled Item: Medical Action INDUSTRIES INC.
The Issue: There is a potential for flaking metal and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Action INDUSTRIES INC.
The Issue: There is a potential for flaking metal and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skyton Bracket Flatscreen
The Issue: Failure of the FS32 Monitor Brackets from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of
The Issue: Standard packed within NEFA kit has been assigned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit...
The Issue: A risk exists during impacting of the acetabular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog...
The Issue: Due to a component failure, ventilators may unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFire BCID2 Panel
The Issue: Elevated rates of false negative results may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
The Issue: Magellan has received reports that control tests of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
The Issue: Magellan has received reports that control tests of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeadCare II Blood Lead Test Kit Catalog Number 70-6762
The Issue: Magellan has received reports that control tests of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access SARS CoV-2 lgG II Reagent
The Issue: SARS-CoV-2 lgG II numerical results may potentially be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access SARS-CoV-2 lgG II Calibrator
The Issue: SARS-CoV-2 lgG II numerical results may potentially be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer...
The Issue: Fifty (50) individual units from Lot D20111130 were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X
The Issue: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X
The Issue: Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin TriIFit TS SIZE 2
The Issue: Units from one batch of TriFit TS size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin TriFit CF SIZE 7
The Issue: Units from one batch of TriFit TS size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.