The Recall Desk
HighFDA (Devices)·Z-1390-2023·Announced 2023-04-19

Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect

Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.

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: Class II medical device recall with a sterilization defect creating infection and vision-loss risks. No illnesses or injuries have been reported; the harm is theoretical. Score is 3 per rubric criterion: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Covidien, LP is recalling 3,228 units of Plain Gut Absorbable Sutures (PLAIN GUT 5/0 18 P-13 X12 model SG-5686 and PLAIN GUT 4-0 18 UD SC-11 DA model SG828-2).

A calibration issue at a contract sterilization supplier may have left affected sutures unsterile. Use of unsterile sutures poses a risk of infection, or vision loss if used in ophthalmologic procedures.

The recalled sutures were distributed worldwide to the United States, Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand. Affected lot numbers are D2G1825FZY, D2H0754FZY, and D2E2595ZY.

Healthcare facilities and surgical centers should immediately verify their inventory against the affected lot numbers and discontinue use of any matched products. Patients who have undergone surgery with affected sutures should contact their healthcare provider.

The recalled product

Product
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
Manufacturer
Covidien, LP
Category
Medical Device — Surgical Sutures
Hazard
Affected units
3,228

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 (5)

  • GTIN: 20884521055756
  • 20884521750118
  • Lot: D2G1825FZY
  • D2H0754FZY
  • D2E2595ZY

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Covidien, LP

See all →