Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2541-2017·Announced 2017-06-21

Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal

Medtronic is recalling specific Polysorb suture products 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 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: The recall is classified as FDA Class II, and the hazard is a potential for premature degradation without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Medtronic is recalling specific lots of Polysorb suture products. The recall involves 478,465 units distributed worldwide, including the United States (including Puerto Rico) and various international markets such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.

The reason for the recall is 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 illnesses, injuries, or deaths associated with this defect.

Healthcare providers and facilities should check their inventory for the specific item numbers and lot codes listed in the official recall notice. If affected products are found, they should be removed from use and returned to Medtronic or the authorized distributor according to the firm's instructions.

The recalled product

Product: Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"…
Manufacturer: Medtronic
Category: Medical Device — Sutures
Hazard: packaging-defect
premature-degradation
Affected units: 478,465

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 →

Same manufacturer · Medtronic

See all →

High
Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
High
Medtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
High
Medtronic Recalls MAXON Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
High
Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
High
Medtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21

Same hazard · packaging defect