Collagen matrix recalled for endotoxin testing methodology issues
TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II device recall involves testing methodology failures with no reported illnesses, injuries, or confirmed product contamination. The recall is precautionary based on gaps in endotoxin testing procedures rather than a confirmed product defect.
Plain-English summary
Revize-X is a collagen matrix medical device used for soft tissue reconstruction. TEI Biosciences recalled 665 units of the product due to possible out-of-specification endotoxin test results. The recall resulted from issues with the company's in-process and finished goods endotoxin testing procedures.
Affected units were distributed nationwide in two sizes (12x6 cm and 10x9 cm). The product is available by prescription only.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients who have received this product should consult their healthcare provider for guidance regarding any concerns.
The recalled product
- Product
- Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 665
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 (2)
- Item No. (UDI-DI): 611-005-001 (10381780357308)
- 611-005-002 (10381780357315).
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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