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 10021–10040 of 38,428 recalls
Recalled Item: Olympus POWERSEAL 5MM
The Issue: An out of specification component preventing the blue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus POWERSEAL 5MM
The Issue: An out of specification component preventing the blue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus POWERSEAL 5MM
The Issue: An out of specification component preventing the blue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
The Issue: Procedure packs contained a recalled product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)
The Issue: An average negative bias of -23% with IMMULITE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GXL acetabular liners
The Issue: Specific GXL acetabular polyethylene liners, packaged in non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog
The Issue: OPS Fiber packaged within specific VenaCure EVLT Procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verify SixCess Challenge Pack. Used to confirm that critical parameters
The Issue: Product contains incorrect chemical indicators in packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Early Bird Bleed Monitoring System Introducer Sheath Set
The Issue: Bleed monitoring system device design error, causing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
The Issue: Siemens has become aware of a potential hardware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q floor- Model No. 10848280 Artis Q ceiling- Model
The Issue: Siemens has become aware of a potential hardware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.