Polysorb recallZ-2601-2018 · Covidien LLC · initiated Jun 15, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential proplylene glycol contamination
FDA root cause category: Nonconforming Material/Component
What the company is doing
All U.S. consignees were notified via Federal Express or certified mail on June 15, 2018, and the letter informs customers of the potential that the suture was contaminated with propylene glycol during the manufacturing process and the actions they should take. Customers are advised to discontinue use of the product and return all inventory of the affected lot to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Recall details
- Recall number
- Z-2601-2018
- Status
- Terminated
- Initiated by the company
- Jun 15, 2018
- Recalling firm
- Covidien LLC
- Quantity
- 972 units
- Product code
- GAM
- FDA submissions
- K981935
- Distribution
- CA, NY & TX
Product description
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Code information (models, lots, serial numbers)
UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Polysorb CL-955Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall5 reports
Product lines
Other devices under the same FDA submission
276 devices cleared under K981935 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Polysorb CL-923Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID321 reports
- Polysorb CL-813Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID274 reports
- Polysorb SL-712Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID185 reports
- Polysorb SL-5687Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID155 reports
- Polysorb CL-914Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID138 reports
- Polysorb GL-885Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID136 reports
- Polysorb SL-691Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID116 reports
- Polysorb CL-925Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID98 reports
- Polysorb GL-182Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID96 reports
- Polysorb GL-223Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID82 reports
- Polysorb GLJ-50-MCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID70 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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