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 7301–7320 of 38,428 recalls
Recalled Item: 3M Attest Super Rapid Readout Biological Indicator
The Issue: Specific lots of 3M Attest Super Rapid Readout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack
The Issue: Specific lots of 3M Attest Super Rapid Readout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Super Rapid Readout Steam Challenge Pack
The Issue: Specific lots of 3M Attest Super Rapid Readout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack
The Issue: Specific lots of 3M Attest Super Rapid Readout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPMI LUMERA 300
The Issue: Surgical microscope for use in ophthalmology may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gladiator
The Issue: The thumb strap of the wrist and thumb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Constellation Vision System
The Issue: Ophthalmic microsurgical vision systems have a new Printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedBank MedPass Software
The Issue: After dispensing a timed dose medication for a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOZO Bilateral Arm L-Dex Software
The Issue: Bilateral L-Dex assessment software does not have the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: exoplan version 3.1 Rijeka Software -A medical software
The Issue: A software library filtering error has been discovered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Information Center iX with Software Version Number 4.x in
The Issue: Patient Information Center (PIC iX) Release 4.x Surveillance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure pack: Presource PBDS Cat. PLMHCSBHF
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure pack: Presource PBDS
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource Pain Tray
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource PBDS Cat. PN33BPCR2
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource PBDS
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.