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Unrated Medical device recall · FDA · Published June 15, 2018

Covidien Polysorb Suture Recall: Potential Proplylene Glycol Contamination

Covidien recalls Polysorb Braided Absorbable Suture 1 36" 90 cm Undy: potential proplylene glycol contamination. Affected units have specific product numbers and lot codes.

🇺🇸 FDA recall #Z-2601-2018Medical deviceCovidien ›
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Contact the company

Recalling firmCovidien LLC60 Middletown Ave · North Haven, CT 06473-3908
✎ GovInfoNow plain-language explainer

Covidien is recalling Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21 due to potential proplylene glycol contamination. This could pose a health risk if the suture is used in medical procedures. Read more at govinfonow.com/recall/70838-covidien-polysorb-suture-recall-potential-proplylene-glycol-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/70838-covidien-polysorb-suture-recall-potential-proplylene-glycol-contamination · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2601-2018

Cite this page

“Covidien Polysorb Suture Recall: Potential Proplylene Glycol Contamination.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70838-covidien-polysorb-suture-recall-potential-proplylene-glycol-contamination. Based on FDA recall #Z-2601-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2601-2018%22&limit=1).

The FDA announced on June 15, 2018, that Covidien LLC voluntarily recalled Polysorb Braided Absorbable Suture due to potential propylene glycol contamination, according to the FDA.

How to tell if you have it

  • Brand: Covidien
  • Product: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21
  • Product Number: CL-955
  • Lot Number: A8C0783X
  • Quantity: 972 units

The hazard

The recall addresses potential propylene glycol contamination in the suture, according to the FDA.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Recent similar product recalls include the Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026), the Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), and the Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026).

How to tell if you have this one

Check for product number CL-955 and lot number A8C0783X on the suture packaging. The unique device identifier (UDI) numbers 10884521043718 and 20884521043715 are also associated with this recall.

  • Brand
    Covidien
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for product number CL-955 and lot number A8C0783X on the suture packaging.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “CA, NY & TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, New York, Texas.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jun 15, 201812. FDA classified it Class II: Aug 2, 201823. Published in FDA’s Enforcement Report: Aug 8, 201834. FDA terminated the recall: May 8, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2601-2018 (June 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2601-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA