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 6021–6040 of 38,428 recalls
Recalled Item: Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a
The Issue: Endotracheal Tube Holder included in certain kits is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assembly
The Issue: There is a galling effect (cold-weld) caused by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preat Nobel Active/Conical-compatible RP Titanium Blank
The Issue: Due to a manufacturing issue, the screw seat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNclog Eye Mask Product Name: UNclog Eye Mask
The Issue: Due to a change in the safety clips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chromophare Surgical Light System
The Issue: Due to insufficient mounting force the stability of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Total T4
The Issue: Four lots of Access Total T4 reagent lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: microStar Reader
The Issue: Permanent discontinuance of the microSTARii medical dosimetry system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARLINK Non-DEHP Solution Set Luer Lock Adapter
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software VERIQA (S070031)
The Issue: Software: If the user excludes voxels from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torrent Suite Dx Software versions 5.14 and earlier used in
The Issue: Torrent Suite Dx Software versions 5.14 and earlier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Substrate
The Issue: On 07 February 2024 Beckman Coulter made the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TENSIVE Conductive Adhesive Gel
The Issue: Natus has become aware that its third-party supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP
The Issue: When a paraPAC plus ventilator is switched to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DLP Vessel Cannula
The Issue: Medtronic is writing to inform you of incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP
The Issue: When a paraPAC plus ventilator is switched to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: natus neurology
The Issue: Natus has become aware that its third-party supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DCA Systems HbA1c Reagent Kit
The Issue: The reason for the recall is that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPII Model Lubinus
The Issue: Due to two complaints, has come to our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPII Model Lubinus
The Issue: Due to two complaints, has come to our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPII Model Lubinus
The Issue: Due to two complaints, has come to our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.