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 12961–12980 of 38,428 recalls
Recalled Item: BIOTRONIK ITREVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK IPERIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Ilestro 7 VR-T
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ITREVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Ilestro 7 DR-T
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Iforia 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Iforia 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK Iperia 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK INVENTRA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ILIVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK INVENTRA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK IPERIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOTRONIK ITREVIA 7
The Issue: There is a potential for premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm
The Issue: Difficulty inserting the biopsy ejector rod into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS
The Issue: Sample Identification (SID) Mismatch with14-Character Barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.