Polysorb Suture Reload Recall, Sterility Issue, Jan 2026
Summary
Health Canada issued a Type I recall for Polysorb Coated Braided Absorbable Single Stitch Reload suturing devices (Model 170071, Lot J5H2924Y) manufactured by Covidien LLC after holes were discovered in both the breather pouch and foil packaging on January 22, 2026. The investigation determined that a post seal machine was causing damage to the suture package, compromising sterility. Healthcare providers using these products should contact the manufacturer at 15 Hampshire Street, Mansfield, Massachusetts for additional information.
“On Jan 22 2026, holes were found in both the breather pouch and the foil. During the investigation into the source of the issue, it was determined that the post seal machine was causing damage to the suture package.”
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What changed
Health Canada classified this as a Type I recall—the most serious category—after Covidien LLC determined that a post seal machine was damaging suture packaging, creating holes in both the breather pouch and foil that compromised product sterility. The affected lot (J5H2924Y) of Polysorb Coated Braided Absorbable Single Stitch Reload devices was distributed prior to the January 22, 2026 discovery date.
Healthcare providers and facilities that have procured Polysorb suture reloads for use with Endo Stitch or Sils Stitch devices should verify their inventory against Lot J5H2924Y and contact the manufacturer directly for guidance. Patients who underwent procedures using potentially affected devices should be monitored according to facility protocols for signs of surgical site infection, though the recall notice does not specify any patient adverse event reports.
What to do next
- Contact the manufacturer if you require additional information.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Polysorb Coated Braided Absorbable Single Stitch Reload For Use With The Endo Stitch And Sils Stitch Suturing Devices
Brand(s)
Last updated
2026-04-24
Summary
Product Polysorb Coated Braided Absorbable Single Stitch Reload For Use With The Endo Stitch And Sils Stitch Suturing Devices Issue Medical devices - Sterility What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Polysorb Coated Braided Absorbable Single Stitch Reload For Use With The Endo Stitch And Sils Stitch Suturing Devices | J5H2924Y | 170071 |
Issue
On Jan 22 2026, holes were found in both the breather pouch and the foil. During the investigation into the source of the issue, it was determined that the post seal machine was causing damage to the suture package.
Additional information
Details
Original published date:
2026-04-24
Alert / recall type Health product recall Category Health products - Medical devices - General and plastic surgery Companies Covidien Llc
15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published by Health Canada Audience Healthcare Recall class Type I Recall date
2026-04-23
Identification number RA-81924
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