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 28001–28020 of 38,428 recalls
Recalled Item: UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists
The Issue: Cook Medical is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karma Flexx Wheelchair Manual Wheelchair.
The Issue: Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE
The Issue: The firm received complaints that the product is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Algostim LLC
The Issue: The implantable pulse generator (IPG) model 2408 had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Algostim LLC
The Issue: The implantable pulse generator (IPG) model 2408 had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Algostim LLC
The Issue: The implantable pulse generator (IPG) model 2408 had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model
The Issue: Siemens' conducting a recall due to a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FMC7 FITC: Model 430918. FMC7 is intended for in
The Issue: Becton, Dickinson and Company (BD) has determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Stage Venous Return Catheter
The Issue: Sorin Group initiated field correction for the Dual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Steri-Vac Gas Sterilizer/Aerator
The Issue: 3M discovered a valve with incorrectly labeled "input"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code:
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code:
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code:
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item
The Issue: Aplicare Castile Soap towelettes included in the Foley
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.