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 7321–7340 of 38,428 recalls
Recalled Item: Presource Fistulogram Pack
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource PBDS
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource PBDS Cat. PNVMNIB21
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource Portacath Pack
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion PLUNGER FLOAT PLATE
The Issue: A force sensor in the occlusion detector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure packs: (1) Presource PBDS Cat. PG33BTO21
The Issue: Packs contain recalled components (equipment drapes, table cover,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gallant VR Implantable Cardioverter Defibrillator: VR ICD Gallant
The Issue: Due to Bluetooth malfunction on a subset of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D
The Issue: Due to Bluetooth malfunction on a subset of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper
The Issue: A damaged foot switch may cause instances where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: remel TODD HEWITT W. CNA (LIM BROTH)
The Issue: On lot of Todd Hewitt Broth w/CNA (LIM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK
The Issue: One lot of KWIK STIK ANA (3 strains)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian 2 System Product Name: Guardian System 2
The Issue: A software update corrected an issue where "low"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGrath Mac 2
The Issue: Laryngoscope blades may contain an ineffective application of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGrath Mac 2
The Issue: Laryngoscope blades may contain an ineffective application of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Functional MR V1.0
The Issue: When exporting regions of interest in DICOM SEGMENTATION
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC...
The Issue: This recall has been initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic...
The Issue: Non-conformances in Veran devices (ig4 Image Guided System,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.