Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal
Medtronic is recalling BIOSYN sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (suture degradation) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic is recalling BIOSYN 4/0 18" VIOLET CV-25 DT sutures, Item Number GMJ34M. The recall involves 478,465 units distributed worldwide, including the United States (including Puerto Rico) and countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.
The recall is being issued because of a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material.
Healthcare facilities and distributors should stop using the affected sutures and contact Medtronic for further instructions. Consumers are unlikely to be directly affected as these products are typically used in clinical settings.
The recalled product
- Product
- Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
- Manufacturer
- Medtronic
- Category
- Medical Device — Sutures
- Affected units
- 478,465
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 (1)
- BIOSYN* 4/0 18" VIOLET CV-25 DT D4K0010X
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic 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 8 products in this recall →Related recalls
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