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 2621–2640 of 38,428 recalls
Recalled Item: Progressa Bed Surfaces
The Issue: The air bladders inside the mattress may move
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter TruSystem 7500 Hybrid (FC)
The Issue: There is a software issue which causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter TruSystem 7500 Hybrid Plus (SC)
The Issue: There is a software issue which causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Floor mounting column TruSystem 7500
The Issue: There is a software issue which causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Floor mounting column TS 7500 U
The Issue: There is a software issue which causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Mobile column TruSystem 7500
The Issue: There is a software issue which causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY
The Issue: Specific Medline Kits were manufactured using Intubation ORAL/NASAL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boppli: Bedside Device Kit
The Issue: Single-use battery-powered blood pressure monitor, for use on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian
The Issue: Adhesive on the back of the lead may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian
The Issue: Adhesive on the back of the lead may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COR Disposable Kit
The Issue: Device is missing the pin in the graft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COR Disposable Kit
The Issue: Device is missing the pin in the graft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits
The Issue: Medical convenience kits containing Medtronic Aortic Root Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits
The Issue: Medical convenience kits containing Medtronic Aortic Root Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits
The Issue: Medline medical procedure kits, containing Medtronic Aortic Root
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits
The Issue: Medical convenience kits containing Medtronic Aortic Root Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1
The Issue: IVX Station Reconstitution Transfer Sets were shipped in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Connecta BD Luer-Lok 360
The Issue: Due to specific lots of luer-lok devices were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory...
The Issue: The RSV target may give a late Ct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.