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 13161–13180 of 38,428 recalls
Recalled Item: Thread-like wire marker
The Issue: This recall has been initiated due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: Manufacturing failed to follow process steps resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Ophthalmic Surgical Procedure Packs
The Issue: Reports have been received concerning mold found on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Feth-R-Kath Catheter
The Issue: Outer coating of the catheter may deteriorate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod DASH Insulin Management System User Guide (OUS Only) Product
The Issue: Certain foreign user guides include a misprint which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Velocity Disposable Bipolar Ablators - Product Usage: intended to be
The Issue: There can be a potential breach of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascadion SM Clinical Analyzer
The Issue: Due to software defect, under certain assay parameters,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConMed Disposable Bipolar Ablators - Product Usage: intended to be
The Issue: There can be a potential breach of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting
The Issue: There can be a potential breach of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-Series Equipment Management System
The Issue: The manufacturer has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number:
The Issue: Y-piece may become detached from the ventilation hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia gas-machine - Product Usage: intended for use in administering
The Issue: Maquet Critical Care AB received complaints where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order...
The Issue: Y-piece may become detached from the ventilation hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order
The Issue: Y-piece may become detached from the ventilation hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number:
The Issue: Y-piece may become detached from the ventilation hose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) )V-402a
The Issue: Due to two (2) issues: 1) The firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole
The Issue: Due to two (2) issues: 1) The firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolve Cell Culture Bags
The Issue: It was identified that tissue culture bags were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duodenoscope and accessories
The Issue: Olympus Medical Systems Corporation (OMSC) has received complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit - Product Usage: Used for Continuous Renal
The Issue: Variability in the performance of the tubing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.