Recall archive / FDA device enforcement
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 ... — FDA record Z-2069-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
- Reason
- Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Classification
- Class II
- Recalling firm
- TEI Biosciences, Inc.
- Quantity
- 14,535 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2069-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Item No. (UDI-DI): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-006 (10381780112648), 606-001-007 (10381780112655), 606-001-008 (10381780112662), 606-001-009 (10381780112679), 606-001-010 (10381780112686), 606-001-012 (10381780112693), 606-001-013 (10381780112709), 606-001-014 (10381780112716), 606-001-015 (10381780112723), 606-001-016 (10381780112730), 606-001-017 (10381780112747), 606-001-018 (10381780112754), 606-002-002 (10381780112761), 606-002-003 (10381780112778), 606-002-005 (10381780112785), 606-003-001 (10381780112792), 606-003-002 (10381780112808), 606-003-003 (10381780112815). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: Nationwide Distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 12, 2023
- Recall initiation date
- May 23, 2023
- Center classification date
- Jul 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.