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 32201–32220 of 38,428 recalls
Recalled Item: APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5
The Issue: A recall of the APTUS Ulna Shortening 2.5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spline Twist Implant
The Issue: Zimmer Dental is recalling Tapered Screw-Vent Implants because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS Operating Room table (ORT200 and ORT300). Intended for use
The Issue: One of the three pins that is used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuum Acetabular System Trabecular Metal Shell with Multi Holes
The Issue: The affected products are missing polar boss threads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model:
The Issue: Incorrect expiration date printed on the MILEX PESSARY
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension HB1C Flex reagent cartridge
The Issue: Certain lots of the reagent cartridges show confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StarMedTec LightTrail¿ Reusable Fibers
The Issue: Product is not cleared for use with lasers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry
The Issue: Firm has identified a small number of Oximetry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model:...
The Issue: Incorrect expiration date printed on the MILEX PESSARY
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee
The Issue: Packaging of a device was compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StarMedTec LightTrail¿ Reusable Fibers
The Issue: Product is not cleared for use with lasers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StarMedTec LightTrail¿ Reusable Fibers
The Issue: Product is not cleared for use with lasers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Software Version 3.1 utilized on the following systems: 1)
The Issue: Calibration may not occur when using calibrator barcode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Selector Kit Sterile single use device A bi-lumen
The Issue: Some specific lots of Selector Tubing may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dharma Cavity Varnish 15mL
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dharma Cavity Varnish with Fluoride
The Issue: During an FDA inspection, it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis Medication Safety Software
The Issue: Smiths Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coloplast Conveen Urine Collection Leg Bag
The Issue: Coloplast is recalling the Conveen Contour Leg Bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Healthcare
The Issue: It has been reported that during use, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.