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 35781–35800 of 38,428 recalls
Recalled Item: uTASWako DCP
The Issue: Product fails to meet the accuracy at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1
The Issue: American Optisurgical, Inc. is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SlingBar 350. Designed to meet the needs for lifting humans.
The Issue: Retrospective review found 4 sling bars that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SlingBar Standard. Designed to meet the needs for lifting humans.
The Issue: Retrospective review found 4 sling bars that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
The Issue: American Optisurgical, Inc initiated a recall of ChloraPrep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ Breathe Medication Cup. For the delivery of liquid medications
The Issue: dislodgement of the "Plate A", if this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SlingBar 360. Designed to meet the needs for lifting humans.
The Issue: Retrospective review found 4 sling bars that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SlingBar Wide 670. Designed to meet the needs for lifting humans.
The Issue: Retrospective review found 4 sling bars that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: adult defibrillation
The Issue: TZ Medical Inc is recalling its P-211-M1 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Micro Introducer Kits under the following labeling: 1)...
The Issue: AngioDynamics Inc., is recalling Micro Introducer Kits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated
The Issue: Unexpected movement during beam delivery may not be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ Breathe Atomizer Model # EZ-100. For the delivery of
The Issue: dislodgement of the "Plate A", if this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one
The Issue: dislodgement of the "Plate A", if this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following...
The Issue: AngioDynamics Inc., is recalling Micro Introducer Kits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation...
The Issue: Biomet Trauma ("Biomet") has initiated a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom Artis systems. C-arm angiographic x-ray system x-ray
The Issue: The firm became aware of a potential issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardio Medical Products
The Issue: Covidien received customer reports of Arcing/Sparking on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01
The Issue: MAQUET has identified a potential issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Active Articulation E1. Intended for use with either primary or
The Issue: Biomet is recalling Active Articulation E1 Hip Bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic...
The Issue: On 4/18/13 HEARTSYNC became aware of a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.