Agency classClass IIOur severity:High FDA (Devices)·Z-1296-2014·Announced 2014-04-02

Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect

Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.

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 involves a medical device with a structural defect (needle attachment strength) that poses a risk of harm during surgical procedures, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is recalling 32,271 units of Sutures, Non-absorbable, Silk, Sterile, Rx only. The affected product is identified by Product Code X-6371M5 and Lot number 02E0801603. These sutures are natural, non-absorbable, sterile, flexible multifilament threads composed of fibroin, indicated for use in soft tissue approximation.

The recall was initiated because the products did not meet minimum needle attachment strength requirements. This defect could potentially compromise the integrity of the suture during surgical use.

The affected units were distributed worldwide, including the United States, Canada, Germany, and Ireland. Healthcare providers and facilities should check their inventory for the specific lot number and product code listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor.

The recalled product

Product: Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species…
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Sutures
Hazard: structural-defect
surgical-complication
Affected units: 32,271

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 (2)

Product Code: X-6371M5
Lot numbers: 02E0801603

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Teleflex Medical 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 6 products in this recall →

Same manufacturer · Teleflex Medical

See all →

Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Low
Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
Moderate
Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
High
Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25

Same hazard · structural defect