TEI Biosciences, Inc. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 11.

Medical DeviceJul 12, 2023

TEI Biosciences PriMatrix Ag Meshed recall — FDA Z-2082-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only recall — FDA Z-2074-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences PriMatrix Fenestrated recall — FDA Z-2078-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm recall — FDA Z-2080-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack) recall — FDA Z-2077-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes recall — FDA Z-2073-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes recall — FDA Z-2069-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only recall — FDA Z-2075-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 recall — FDA Z-2079-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only recall — FDA Z-2072-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Medical DeviceJul 12, 2023

TEI Biosciences SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only recall — FDA Z-2070-2023

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

Class IIFDA: OngoingTEI Biosciences, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies TEI Biosciences, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.