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 35581–35600 of 38,428 recalls
Recalled Item: Siemens MEVATRON series
The Issue: The information regarding the FILM Mode calibration may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE with syngo RT Therapist version 4.3 Product Usage: The
The Issue: The potential for a safety issue, for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for
The Issue: Customers are resetting the default values outside recommended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All Elekta digital accelerators with electrons and beam modulator
The Issue: Customers are resetting the default values outside recommended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in
The Issue: Carl Zeiss Microscopy, LLC is recalling the Polarizer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alair Bronchial Thermoplasty Catheter
The Issue: Boston Scientific has discovered an inconsistent "Use By"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RigiflexTM 11 Single-Use Achalasia Balloon Dilator
The Issue: Product labeled with incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material...
The Issue: Incorrect sized renal sheath was packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NephroMax high Pressure Nephrostomy Balloon Catheter. Material...
The Issue: Incorrect sized renal sheath was packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite
The Issue: DJO, LLC has recently identified a product safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent
The Issue: Beckman Coulter has confirmed customer reports of LACT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE(R) Bone Graft
The Issue: Kits contain a collagen sponge recalled by Integra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR S4 with Variable Spot Scanning Excimer System (STAR S4)
The Issue: Under specific conditions, there is an unlikely potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in
The Issue: Recall was initiated because a manufacturing issue was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.