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 16701–16720 of 38,428 recalls
Recalled Item: Medivators Endo Smartcap Endoscope Tubing.
The Issue: Medivators is recalling Endo SmartCap Tubing due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivators Endo Smartcap Endoscope Tubing.
The Issue: Medivators is recalling Endo SmartCap Tubing due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivators Endo Smartcap Endoscope Tubing. . Packaged as Contents 1
The Issue: Medivators is recalling Endo SmartCap Tubing due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Encina HA Femoral Stem
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratum Foot Plating System-NL LP Screw 3.5x50mm ST
The Issue: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower
The Issue: The devices have potential cybersecurity vulnerabilities, which can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas infinity central lab / cobas infinity core license-a Calculator/Data
The Issue: Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit
The Issue: The safety cap attached to needles within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit
The Issue: The safety cap attached to needles within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit
The Issue: The safety cap attached to needles within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit
The Issue: The connector piece to the PEG tube does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit
The Issue: The connector piece to the PEG tube does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Star 8 Rolling Walker/Rollator
The Issue: Walkers within the identified serial range have the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite Optilite Rheumatoid Factor Kit
The Issue: Assigned Rheumatoid Factor (RF) calibrator value for calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TorFlex Transseptal Guiding Sheath
The Issue: There is a remote potential for the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NRG RF Transseptal Kit
The Issue: There is a remote potential for the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxymetry Cable
The Issue: Intermittent communication due to inconsistent crimping of connectors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legacy 3 Implant
The Issue: Some dental implant packages contain incorrect implants, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker
The Issue: When the UniCel DxH Slidemaker Stainer and UniCel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software versions syngo CT VB20 running on the following Siemens
The Issue: Software issue identified in the software versions syngo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.