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 29441–29460 of 38,428 recalls
Recalled Item: Hemocor High Performance Hemoconcentrator
The Issue: Hemoconcentrators may exhibit low ultrafiltration performance that is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Line >34 Weeks Kit . Cardiology department. The Central Line
The Issue: The print plate artwork for this lot was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A
The Issue: Flow restriction issues in a trifurcated IV set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage:
The Issue: to improperly characterize tissue within the jaws,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.4
The Issue: Gridlock screw driver bits for the Gridlock Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T
The Issue: Infant Heel warmers may break during activation resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N
The Issue: Infant Heel warmers may break during activation resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Symbia S Series system
The Issue: Fuses with the improper amperage rating were installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Intevo Series system
The Issue: Fuses with the improper amperage rating were installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Symbia T Series
The Issue: Fuses with the improper amperage rating were installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001
The Issue: AngioJet products were distributed with an incorrect use-by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001
The Issue: AngioJet products were distributed with an incorrect use-by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioJet AVX Thrombectomy Set: UPN 105039-001
The Issue: AngioJet products were distributed with an incorrect use-by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004
The Issue: AngioJet products were distributed with an incorrect use-by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU480 Chemistry Analyzers
The Issue: Beckman coulter has received complaints regarding leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU680 Chemistry Analyzers
The Issue: Beckman coulter has received complaints regarding leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU5800 Chemistry Analyzers
The Issue: Beckman coulter has received complaints regarding leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+
The Issue: There is a probability the hand piece may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow International
The Issue: saline leakage from unsecured connections between the Touhy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Kits with Peel-Away Sheath Component
The Issue: the catheter peel-away component hub tabs may prematurely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.