TEI Biosciences, Inc. recall records

17 reported ongoing

17 records in this archive. Latest source date May 23, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

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 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16...

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm...
FDA device enforcement

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-Ova...

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval,...
FDA device enforcement

SurgiMend 2.0; 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, 20x25cm, 10x15cm Semi-...

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10...
FDA device enforcement

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, 10x2...

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10...
FDA device enforcement

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestra...

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10...
FDA device enforcement

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:...
FDA device enforcement

PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).

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

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution.

Official source for PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25...

Reasons in these listed records

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

These examples come from this result page and are not a ranking of every recall reason.

Checking TEI Biosciences, Inc.

Is there a recall on tei biosciences, inc. right now?

This archive contains 17 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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