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Lower risk Medical device recall · FDA · Published February 15, 2019

Covidien Kendall SCD Express Sterile Sleeves: Sterility Risk in Medical Use

Covidien recalls Kendall SCD Express Sterile Sleeves (Thigh Length) Model 9736 due to failure to meet sterility requirements. Product distributed without sterilization prior to distribution.

🇺🇸 FDA recall #Z-1041-2019Medical deviceCovidien ›
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Contact the company

Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer

Covidien is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) Model 973: they were distributed without proper sterilization, meaning they may not be sterile. This could lead to infections if used in medical procedures. Read more at govinfonow.com/recall/68996-covidien-kendall-scd-express-sterile-sleeves-sterility-risk-in-medical.

Source Summary by GovInfoNow · govinfonow.com/recall/68996-covidien-kendall-scd-express-sterile-sleeves-sterility-risk-in-medical · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1041-2019

Cite this page

“Covidien Kendall SCD Express Sterile Sleeves: Sterility Risk in Medical Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68996-covidien-kendall-scd-express-sterile-sleeves-sterility-risk-in-medical. Based on FDA recall #Z-1041-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2019%22&limit=1).

Covidien LLC recalled Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736, because they do not meet sterility requirements, according to a Food and Drug Administration announcement on Feb. 15, 2019.

How to tell if you have it

  • Brand: Covidien
  • Product: Kendall SCD Express Sterile Sleeves (Thigh Length)
  • Model Number: 9736
  • Lot Number: 83410S09D
  • Quantity: 25 units
  • Distribution states: CA, NJ, WA

The hazard

The product does not meet sterility requirements because the product labeled as sterile was distributed without undergoing sterilization prior to distribution.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since Aug. 7, 2017. Other recent recalls of similar products include Covidien EndoFLIP System recall (May 13, 2026), Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), and Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026). Other recent recalls of similar products include Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), DeRoyal Covaderm Plus Dressing Recall (May 18, 2026), and Medline Curad Germ-Shield Bandages Recall (Oct. 27, 2025).

How to tell if you have this one

Check for the model number 9736 on the sleeve packaging. The lot number 83410S09D is 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 the model number 9736 and lot number 83410S09D on the sleeve packaging.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: 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: not listedTXFlorida: not listedFL

FDA distribution: “The products were distributed to the following US states: CA, NJ, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, New Jersey, Washington.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Feb 15, 201912. FDA classified it Class II: Mar 22, 201923. Published in FDA’s Enforcement Report: Apr 3, 201934. FDA terminated the recall: Jul 24, 2020420192020
  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-1041-2019 (February 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1041-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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