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 36261–36280 of 38,428 recalls
Recalled Item: Covidien Endo GIA AutoSuture Universal Loading Unit
The Issue: Single Use Loading Unit contained two staples loaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and
The Issue: Microbiologics Inc is initiating a voluntary recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANTI-BORRELIA (LYME) MICROPLATE EIA Kit
The Issue: Multiple incidents of low-reacting assay plates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System. Radiation treatment planning.
The Issue: The beam is displayed at the "gantry" angle,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8
The Issue: Issue with optional neuro-endoscopy module detected under specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DBS Therapy for Dystonia Kit
The Issue: There is a potential for lead damage due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack
The Issue: Increased levels of false positives in BD Probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DBS Lead Kit for Deep Brain Stimulation
The Issue: There is a potential for lead damage due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1)
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's
The Issue: LIFEPAK CR Plus or LIFEPAK Express Automated External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer NexPosure
The Issue: Possibility that the inner pouch may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avex CX Suite
The Issue: Orthodontic brackets distributed was incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System (VITROS 5
The Issue: Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR MD1.0 General Set
The Issue: The cassettes were shipped with the wrong IP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number
The Issue: Increased risk of failure at the driver tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTERNAL HEX RECON SCREW
The Issue: 75 mm screws were packaged and labeled using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTERNAL HEX RECON SCREW
The Issue: 75 mm screws were packaged and labeled using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Technocut Plus
The Issue: Pouch labeling/printing errors and defective packaging resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.