🔍 RecallPedia

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

Class I - Dangerous
🏥 Medical Devices Recalled: May 23, 2023 TEI Biosciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item No. (UDI-DI): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).
  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:
TEI Biosciences, Inc.
Reason for Recall:
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

Product Codes/Lot Numbers:

Item No. (UDI-DI): 606-300-002 (10381780113072), 606-300-004 (10381780113089) 606-300-006 (10381780113096), 606-300-008 (10381780113102), 606-300-009 (10381780113119), 606-300-016 (10381780113126), 606-300-017 (10381780113133), 606-300-019 (10381780113140), 606-300-020 (10381780113157), 606-300-021 (10381780113164), 606-300-022 (10381780113171), 606-304-001 (10381780113188), and 606-304-002 (10381780113195).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2074-2023

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