Records and reported status
May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval,... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 1... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, ... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 ... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, ... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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:... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 ... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported 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... May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm. May 23, 2023 FDA device enforcement
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class II Reported ongoing
Distribution: Domestic: Nationwide Distribution.
Official source for TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
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.