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 3041–3060 of 38,428 recalls
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN:...
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Continu-Flo Solution Set with Duo-Vent Spike
The Issue: Specific lots of Solution Sets with Duo-Vent Spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as
The Issue: Lipoprotein (a) on Roche Cobas c501 with nmol/l
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as
The Issue: Lipoprotein (a) on Roche Cobas c501 with nmol/l
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Solution Set with Duo-Vent Spike
The Issue: Specific lots of Solution Sets with Duo-Vent Spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Clearlink System Solution Set with Duo-Vent Spike
The Issue: Specific lots of Solution Sets with Duo-Vent Spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: N/A Product Name: Repeater Bone Tamp Model/Catalog Number:
The Issue: Due to incompatibility of bone tamp (Rev A)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn
The Issue: There is an issue with the ventilator battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breathe Technologies
The Issue: There is an issue with the ventilator battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn
The Issue: There is an issue with the ventilator battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn
The Issue: There is an issue with the ventilator battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each)
The Issue: During the assembly of the cartridge to its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)
The Issue: During the assembly of the cartridge to its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KARL STORZ - ENDOSKOPE
The Issue: Scope IFUs contain a reprocessing modalities that have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KARL STORZ - ENDOSKOPE
The Issue: Scope IFUs contain a reprocessing modalities that have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.