The Recall Desk
HighFDA (Devices)·Z-2544-2017·Announced 2017-06-21

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.

What this means for you

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
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

Same manufacturer · Medtronic

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Same hazard · material degradation

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