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.

38,428 total recalls
0 this month

Showing 3061–3080 of 38,428 recalls

December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: KARL STORZ - ENDOSKOPE

The Issue: Scope IFUs contain a reprocessing modalities that have

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Becton Dickinson & Co.

Recalled Item: BD PCR Cartridges used with MAX System. Model Number: 437519

The Issue: for signal drift in specific lots of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Ortho-Clinical Diagnostics, INc.

Recalled Item: VITROS Product Name: VITROS XT 7600 Integrated System

The Issue: The VITROS XT 7600 Integrated System software versions

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Ortho-Clinical Diagnostics, INc.

Recalled Item: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog

The Issue: The VITROS 5600 Integrated System software versions 3.8.0

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Ortho-Clinical Diagnostics, INc.

Recalled Item: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog

The Issue: The VITROS 3600 Immunodiagnostic System software versions 3.8.0

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Jinan Bodor Cnc Machine Co Ltd

Recalled Item: Bodor P and C series laser cutting machines

The Issue: Non-compliant laser products

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing