TEI Biosciences, Inc.

Complete recall history across all FDA and CPSC categories — 17 total recalls

TEI Biosciences, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by TEI Biosciences, Inc.

Date Product Reason Class
May 23, 2023 SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only... Possible out of specification endotoxin test results due to issues with in-pr... Class II
May 23, 2023 PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1... Possible out of specification endotoxin test results due to issues with in-pr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.