TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2070-2023)

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 PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2070-2023

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: 22,163 units

Code Information:

Item No. (UDI-DI): 606-004-100 (10381780112822), 606-004-101 (10381780112839), 606-004-102 (10381780112846), 606-004-103 (10381780112853), 606-004-104 (10381780112860), 606-004-105 (10381780112877), 606-004-106 (10381780112884), 606-004-107 (10381780112891), 606-004-108 (10381780112907), 606-004-109 (10381780112914), 606-004-110 (10381780112921), 606-005-001 (10381780112938), 606-005-002 (10381780112945), 606-007-001 (10381780357322).

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated