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 12341–12360 of 38,428 recalls
Recalled Item: Nonsterile Radial/Femoral Angiography Drape
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Femoral Angiography Drape
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Radial/Femoral Angiography Drape
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse
The Issue: Products may be contaminated with micro-organisms Burkholderia cepacia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems
The Issue: The high and low level "Quality Controls" demonstrate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90. radiography and fluoroscopy system
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.