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 6781–6800 of 38,428 recalls
Recalled Item: 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL:
The Issue: Sodium chloride irrigation USP, and sterile water for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML...
The Issue: Sodium chloride irrigation USP, and sterile water for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A
The Issue: Sodium chloride irrigation USP, and sterile water for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID
The Issue: Sodium chloride irrigation USP, and sterile water for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE
The Issue: Sodium chloride irrigation USP, and sterile water for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon
The Issue: Certain factory settings for the device were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)-
The Issue: Firmware of the Interface Module with Roche Cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion
The Issue: Ceiling mounted L-arm contains a rotation cover that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura
The Issue: Ceiling mounted L-arm contains a rotation cover that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE PVP SOLUTION
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE POVIDONE
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE BETADINE
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE PVP
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE STERILE PREP STICK
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE PVP SLN KIT
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PVP SOLUTION SING STRL
The Issue: The product description on the labeling includes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTUM TTC BILIARY BALLOON DILATOR
The Issue: Nonconforming devices while manufactured correctly, do not comply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.