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 4541–4560 of 38,428 recalls
Recalled Item: GM60A. Digital Diagnostic Mobile X-Ray System.
The Issue: for the anti-fall system of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic ENT Ultra Round Steel Cutting Bur
The Issue: Product was distributed past expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013...
The Issue: Invalid Controls. The Low Control is out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
The Issue: During the assembly of the FRT250 cartridge assembly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
The Issue: It was confirmed that fibrinogen in patient plasma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe systems with software version VD15B in combination with
The Issue: If the Sensis documentation functionality is used during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for...
The Issue: Devices were labeled with an expiration date of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe systems with software version VD15B in combination with
The Issue: If the Sensis documentation functionality is used during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe systems with software version VD15B in combination with
The Issue: If the Sensis documentation functionality is used during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis Vibe systems with software version VD15B-Intended to be used
The Issue: If the Sensis documentation functionality is used during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPince Ultra Full Core Biopsy Instrument: : 360-1080-01
The Issue: Holes have been identified in biopsy instrument packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable 5 Lead Cable and Lead Wire System
The Issue: Disposable 5 lead cable and lead wire system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMINOS Lotus Max -Intended to visualize anatomical structures by converting
The Issue: The support arm may unintentionally lower resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max -Intended to visualize anatomical structures by converting
The Issue: The support arm may unintentionally lower resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF Max- Intended to visualize anatomical structures by converting
The Issue: The support arm may unintentionally lower resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multitom Rax -Intended to visualize anatomical structures by converting an
The Issue: The support arm may unintentionally lower resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
The Issue: Affected product has an increased risk of postoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heparin
The Issue: Due to packaging defects, sterility assurance and heparin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heparin
The Issue: Due to packaging defects, sterility assurance and heparin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobra
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.