Data Foundry

Medical device recalls 2018

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21 — Class II medical device recall Z-2601-2018

Terminated recall by Covidien LLC, reported 2018-08-08, distributed in CA, NY, TX. Potential proplylene glycol contamination

Recall numberZ-2601-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCovidien LLC, North Haven, CT, United States
Recall initiated2018-06-15
Classified2018-08-02
Reported by FDA2018-08-08
Terminated2019-05-08
DistributedCA, NY, TX
Quantity972 units
UPC / GTIN / UDI-DI10884521043718, 20884521043715
Lot numbersA8C0783X

Product

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

Reason for recall

Potential proplylene glycol contamination

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2601-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.