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 3501–3520 of 38,428 recalls
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lab Kit
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URINE COLLECTION VHC
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clean Catch Kit
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URINE KIT W/BD CUP
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UA KIT
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URINE COLLECTION KIT
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URINE KIT
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URINALYSIS KIT 4
The Issue: Specimen container included in kits is labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic
The Issue: for package seal to be out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivalon Eye Wick 20cm- Intended to be used for the
The Issue: for package seal to be out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivalon Anatomical Nasal Packing with Airway Tube and String
The Issue: for package seal to be out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-X Rover Mobile X-ray System
The Issue: Mobile x-ray system receiving/storage(operation) requirements to be followed:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allegedly counterfeit batteries manufactured by CSB batteries being used with
The Issue: ICU Medical has received reports of allegedly counterfeit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in
The Issue: for falsely depressed auto-diluted results for samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.