Agency classClass IIOur severity:High FDA (Devices)·Z-0844-2024·Announced 2024-02-07

Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization

Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.

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: FDA Class II device with potential for serious harm (wound dehiscence and hemorrhage) where no injuries or hospitalizations have been reported. The hazard is theoretical, based on excess sterilization parameters, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Covidien LP is recalling specific lots of Surgilon Braided Nylon sutures, a surgical medical device. The recalled products include models 4-0, 3-0, 2-0, and 1. Approximately 46,812 units were distributed in the United States and 68,976 units were distributed internationally.

Specific lots of these sutures were sterilized using gamma radiation doses that exceeded the FDA-approved range. This excess sterilization may cause the sutures to lose strength over time. Weakened sutures could lead to serious complications including wound dehiscence (opening of the surgical wound) and hemorrhage or blood loss.

Affected sutures were distributed worldwide, including throughout the United States and to multiple international locations including Australia, Belgium, France, Germany, Japan, the United Kingdom, and other countries.

The recalled product

Product: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
Manufacturer: Covidien LP
Category: Medical Device — Surgical Sutures
Hazard: tensile-failure
wound-dehiscence
hemorrhage

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)

Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Covidien LP 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 2 products in this recall →

Same manufacturer · Covidien LP

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Same hazard · tensile failure