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 24921–24940 of 38,428 recalls
Recalled Item: StarClose SE Vascular Closure System
The Issue: Abbott Vascular is recalling the StarClose SE Vascular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Impaction Fixture
The Issue: During the Turon assembly, the impaction forces caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: It has been observed during testing that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire
The Issue: CSI is recalling three lots of VIPERWIRE ADVANCE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SynchroMed II implantable drug infusion pump
The Issue: Medtronic received a complaint that there was an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube
The Issue: Smiths Medical became aware that one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel
The Issue: Test organisms exhibit poor growth when grown using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turon Impaction Fixture
The Issue: During the Turon assembly, the impaction forces caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK TPOAb CONTROL SET
The Issue: The label contains two different methodologies. Quality Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK TgAb CONTROL SET
The Issue: The label contains two different methodologies. Quality Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SharkCore Fine Needle Biopsy System (25GA)
The Issue: Handle may break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arkon Anesthesia Delivery System
The Issue: Spacelabs has received reports of the Arkon Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BNX Fine Need Aspiration System (19GA)
The Issue: Handle may break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SharkCore Fine Needle Biopsy System (22 GA)
The Issue: Handle may break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SharkCore LG Fine Needle Biopsy System (19GA)
The Issue: Handle may break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BNX Fine Need Aspiration System (22GA)
The Issue: Handle may break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Raindrop Near Vision Inlay
The Issue: ReVision Optics has updated the instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with...
The Issue: The Contains Latex symbol was not printed onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU)
The Issue: The Contains Latex symbol was not printed onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #...
The Issue: The Contains Latex symbol was not printed onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.