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 33401–33420 of 38,428 recalls
Recalled Item: Synergy XVI Intended for radiation therapy treatment.
The Issue: XVI can incorrectly calculate the target position of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture
The Issue: CP Medical, Inc., is recalling one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
The Issue: Software issues with ACUSON SC2000 ultrasound with software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and
The Issue: malfunction due to a software issue for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gluma Desensitizer Power Gel Product Usage: Usage: This is a
The Issue: The firm discovered that the Gluma Desensitizer Power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enaly 1000 BT-12 Ozone Generator
The Issue: William Domb is recalling the Enaly 1000 BT-12
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump model 8100 with software version 9.1.18 and software
The Issue: CareFusion is recalling the Alaris Pump model 8100
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery MR450
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access
The Issue: leaking of No Foam solution from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31....
The Issue: Ventilation and alarms of a HAMILTON-G5 ventilator can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible
The Issue: It was discovered internally that the face of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket
The Issue: The hose could separate from the blanket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: illumipro-10 Incubator/Reader
The Issue: Illumipro-10 instruments may have Block B chambers operating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExploR 7x26mm Modular Radial Stem
The Issue: This lot of the ExploR Modular Radial Stem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt...
The Issue: AIC (USA) received information regarding 3 complaints in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb
The Issue: Out of specification results for one of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as
The Issue: Bond Ready to Use Primary Antibody Thyroglobulin does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Recalled product is a component of the Newport Medical Instruments
The Issue: Reports of the audible alarm not sounding when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RetractaBed
The Issue: All configurations of the SS Retractabed, Clinical Contour,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RetractaBed
The Issue: All configurations of the SS Retractabed, Clinical Contour,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.