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 35921–35940 of 38,428 recalls
Recalled Item: 2008 MeDS Pump
The Issue: Product is being recalled because the combination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14203-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14212-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14210-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14206-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14219-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14217-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14200-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14211-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: List No. 14207-28
The Issue: It was discovered that there was a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog#
The Issue: The firm is recalling the specific lot due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic
The Issue: In rare instances, channel shifted results have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3DKnee e+ Tibial Insert. The insert is used along with
The Issue: U.S. Agent contacted Director Commercial Logistics, notifying him
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The UF-1000i is a fully automated urine particle analyzer intended
The Issue: The current Century Break patch did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Optisurgical's TX1 Tissue Removal System Console. The console is
The Issue: The recall has been initiated due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***. No.***466F220A
The Issue: Correction to provide clarification and additional labeling to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The CEP 8 SpectrumGreen (SG) ASR Probe Kit
The Issue: 20 kits of CEP 8 SG ASR Probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integrity 1.1. Integrity is the interface and control software for
The Issue: The problem is that the "static tolerances" from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45
The Issue: On March 28, 2013, Custom Spine, Inc. issued
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.