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 23841–23860 of 38,428 recalls
Recalled Item: 3DKNEE(TM) SYSTEM e+
The Issue: Mis-pack. A size 6 Left 3DKnee Tibial Insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0
The Issue: Tube arm assembly could fall down due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 168 cm (66") Appx 2.6 ml
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit w/3 Ext Sets
The Issue: The connection between the Female Luer and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle
The Issue: ROTH MOBELI grab handles could detach and patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(R) FEM CONE IMPACTOR HEADS: a)
The Issue: The incorrect Loctite adhesive was used to assemble
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(R) TIB CONE IMPACTOR HEADS: a)
The Issue: The incorrect Loctite adhesive was used to assemble
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane
The Issue: The kit was packaged with the incorrect introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LX3 Floor Stand for LuxOR Ophthalmic Microscope
The Issue: Multiple shipments or forceful impact to a caster
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium iCAST Balloon Expandable Covered Stent
The Issue: Firm received a complaint that a customer who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #:
The Issue: Instructions for use (IFU) is updated to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.