Revize Collagen Matrix Recalled for Potential Endotoxin Testing Issues
TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.
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: This is an FDA Class II recall of a surgical-grade medical device with potential endotoxin contamination, a high-risk pathogen in soft tissue reconstruction applications. No illnesses, injuries, or hospitalizations have been reported. The underlying issue involves testing procedure failures rather than confirmed contamination, and the absence of reported adverse events limits the score below 4.
Plain-English summary
TEI Biosciences, Inc. is recalling 199 units of Revize Collagen Matrix, a medical device used for soft tissue reconstruction. The product is supplied in three sizes (10x10 cm, 4x12 cm, 4x16 cm) and was distributed nationwide in the United States.
The recall was initiated due to possible out-of-specification endotoxin test results. Issues identified in in-process and finished goods endotoxin testing procedures have raised concerns about whether the distributed products meet safety specifications for endotoxin levels.
Healthcare facilities and providers using Revize should contact TEI Biosciences for instructions on product return or management. The FDA classifies this as a Class II recall.
The recalled product
- Product
- Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 199
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): 611-001-001 (10381780357292)
- 611-001-002 (10381780357278)
- 611-001-003 (10381780357285).
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.
See all 17 products in this recall →Related recalls
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