Medtronic Recalls Endo Stitch Polysorb Sutures Due to Seal Defect
Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the 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 specific lots of Endo Stitch Polysorb sutures, including item numbers 170052, 170053, 170056, and 170057. The recall involves 478,465 units distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall was initiated due to a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and facilities should check their inventory for the affected item numbers and lot codes listed in the recall notice. Users should stop using the affected sutures and contact Medtronic for further instructions or replacement.
The recalled product
- Product
- Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
- Manufacturer
- Medtronic
- Affected units
- 478,465
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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