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 35841–35860 of 38,428 recalls
Recalled Item: Tracoe Mini 3.0mm Tube
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior
The Issue: Alcon is conducting a Medical Device Removal for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent
The Issue: Beckman Coulter initiated the recall for the Lactate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an
The Issue: A defect in the controller board can lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended
The Issue: Bard Peripheral Vascular (BPV) has confirmed that some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The
The Issue: The firm initiated recall of Alere" hCG Combo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Hand Switch - Electric Pen Drive
The Issue: Synthes received a complaint from a customer in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray systems Product Usage: The Brilliance CT 64
The Issue: Philips Healthcare received reports from the field that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris
The Issue: The firm is recalling these power cables due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom 1000 Bed
The Issue: Complaints have been reported for brakes disengaging when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus
The Issue: The Liquichek" ToRCH Plus IgM Control - Positive,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic
The Issue: AT rare, extremely high glucose levels (1024 mg/dL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The
The Issue: Labeled incorrectly as a Blade Up configuration instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cypress Medical Products LLC
The Issue: Cypress Medical Products LLC is voluntarily recalling one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)
The Issue: Ethicon Endo-Surgery is initiating a voluntary recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays)
The Issue: Ethicon Endo-Surgery is initiating a voluntary recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)
The Issue: Ethicon Endo-Surgery is initiating a voluntary recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various types of Fetal Bovine Serum Bovine sourced Animal Sera
The Issue: Current product labeling band data sheets state that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curity I.V. Start Kit
The Issue: On March 26, 2013 Covidien received a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BBL DrySlide Oxidase Kit
The Issue: In-vitro diagnostic agents were placed into incorrect packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.