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 28381–28400 of 38,428 recalls
Recalled Item: Oxford Knee System Tibial Resector Body Tube & Guides Product
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage:
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Distaflo Vascular Bypass Graft
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Distaflo Vascular Bypass Graft
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-piece Nebulizer with in-line connectors
The Issue: Reports that the T-piece does not fit on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InVision-Plus CS Needleless IV Connector
The Issue: for the female luer component of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InVision-Plus and InVision-Plus Junior Needleless IV Connector
The Issue: for the female luer component of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue Measurement Module X1 Model: M3001A
The Issue: The ST elevation alarm on the Patient Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue Module Measurement X2 Model: M3002A
The Issue: The ST elevation alarm on the Patient Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters
The Issue: Report by a customer of an open package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ottobock Modular Polycentric EBS Knee Joint 3R60
The Issue: Otto Bock HealthCare GmbH is recalling Modular Polycentric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes
The Issue: Incorrect cannula of the sheath introducer (smaller than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The e.cam Dual Signature Gamma Camera system. Used to detect
The Issue: To provide operator instruction manuals for the e.cam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: This reagent is for in vitro diagnostic use. Pax-5 (1EW)
The Issue: The Bond" Polymer Refine Detection and Novolink" Polymer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PharmaCaribe PulmoSal 7% Sodium chloride
The Issue: Vials were labeled as USP 7% Hypertonic saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQURE System
The Issue: The AQURE System has a design error regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur PSA Assay
The Issue: PSA assay is not meeting the High Dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliA SmDP Well
The Issue: All equivocal and positive results (greater or equal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRIdian ViewRay Radiation Therapy System
The Issue: The system loaded a completion fraction in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BacT/ALERT¿ SN
The Issue: Bottles may have been exposed to non-normal shipping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.