TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2074-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2074-2023

Event ID: 92481

Reason for Recall:

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Status: Ongoing

Product Quantity: 13,390 units

Code Information:

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).

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated