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 36101–36120 of 38,428 recalls
Recalled Item: PrimaConnex Tapered Implant TC
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeCare PCA Infusion System with Hospira MedNet Software
The Issue: Screw rotation error occurring when the pump detects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeCare PCA 3
The Issue: Screw rotation error occurring when the pump detects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LifeCare PCA Plus II infusion pump system is designed for safe
The Issue: Hospira has received reports of PCA pumps not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PCA 3 system cam be used in a wide range of clinical settings
The Issue: Hospira has received reports of PCA pumps not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LifeCare Pump Model 4200 PCA Infuser makes possible the
The Issue: Hospira has received reports of PCA pumps not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeCare PCA infusion system with Hospira MedNet software allows clinicians
The Issue: Hospira has received reports of PCA pumps not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture
The Issue: A post market safety review following several customer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery
The Issue: A number of MEDICYL-e Portable Oxygen Systems may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APLIF Implants and Instruments
The Issue: Spinal Solutions is recalling the APLIF system because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product
The Issue: Ormco Corporation is voluntarily recalling one (1) lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA
The Issue: The firm has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter)
The Issue: End users of the DeVilbiss Disposable Suction Container/Filter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge Group battery modules for use with Maquet SERVO-i
The Issue: When using the SERVO-i on battery power, in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers:
The Issue: Orthopedic Alliance is recalling Blue & Gold Implants
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)
The Issue: It has come to the attention of MAQUET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torrent" irrigation tubing. Product Usage: The Torrent irrigation system...
The Issue: The firm was notified by their customers that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a
The Issue: Unapproved medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENESYS Cross FT Suture Anchor with Two #2 (5 metric)
The Issue: Incorrect blue/white suture was used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.