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 5721–5740 of 38,428 recalls
Recalled Item: Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga
The Issue: Due to complaints of particulates, residue, occlusions, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x
The Issue: Products may not be heparin coated as indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System
The Issue: Elekta has become aware that Disposable Biopsy Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile convenience kits: a. Medline Retrograde PK-22025203-LF
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kit: Medline Neuro IR Pack
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile convenience kits: Medline Open Heart CDS
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile convenience kits: a. Medline Delivery
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile convenience kit: Medline Birthing Room Pack
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF
The Issue: Surgical convenience kits containing Pure Pouch component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude Guide Sheath Roadster
The Issue: Their is a potential that sheaths labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude Guide Sheath Roadster
The Issue: Their is a potential that sheaths labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve
The Issue: Due to a manufacturing variation of the irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Keller Funnel 2
The Issue: Their is a potential that breast implants lack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 - AST Test kits (in vitro diagnostic test
The Issue: Ceftriaxone (cro02n) concentration errors associated with specific recently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic...
The Issue: Safety Information: Complaints describe complications/adverse events that includ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Knee System AS Tibial Bearing / DCM ArCom
The Issue: damage to the Vanguard Knee System AS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number:
The Issue: Received complaints that bottles assembled with one batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.