TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2071-2023)

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 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2071-2023

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: 52 units

Code Information:

Item No. (UDI-DI): 606-005-003 (10381780112952) and 606-005-004 (10381780112969).

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated