🔍 RecallPedia

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2023 Olympus Corporation of the Americas Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes 00815686021313; INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes 00815686021306; INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021290; INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes 00815686021276; INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021269; INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes 00815686021153; INS-5700 SPiN EWC Biopsy Guide Kit 00815686021108. All serial numbers and all lot numbers
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympus Corporation of the Americas
Reason for Recall:
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit

Product Codes/Lot Numbers:

Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes 00815686021313; INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes 00815686021306; INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021290; INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes 00815686021276; INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021269; INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes 00815686021153; INS-5700 SPiN EWC Biopsy Guide Kit 00815686021108. All serial numbers and all lot numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2660-2023

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