Soft tissue repair matrix recalled due to possible endotoxin contamination
TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The recall stems from endotoxin testing methodology deficiencies in a medical device used for soft tissue repair—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
TEI Biosciences, Inc. is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix in three sizes: 5x6 cm, 6x10 cm, and 3x3 cm (item numbers 6495-9-001, 6495-9-004, and 6495-9-006). This prescription medical device is used for soft tissue repair.
The recall was initiated due to possible out-of-specification endotoxin test results. Issues with the in-process and finished goods endotoxin testing procedures led to uncertainty about whether some units meet specification requirements. Endotoxins are bacterial compounds that can trigger inflammatory reactions if present at elevated levels.
The affected units were distributed nationwide throughout the United States. No illnesses or injuries have been reported associated with this recall.
The recalled product
- Product
- TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 4,832
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item No. (UDI-DI): 6495-9-001 (10381780113621)
- 6495-9-004 (10381780113638)
- 6495-9-006 (10381780113645).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by TEI Biosciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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