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Use caution Medical device recall · FDA · Published January 3, 2020

Zimmer Tourniquet Cuff Recall: Dual Bladder Leak Risk

Zimmer recalls sterile disposable tourniquet cuffs with dual bladders due to potential leak causing both to inflate/deflate. Affected items have specific lot numbers and item codes.

🇺🇸 FDA recall #Z-1356-2020Medical deviceZimmer ›
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Recalling firmZimmer Surgical Inc200 W Ohio Ave · Dover, OH 44622-9642
✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer is recalling sterile disposable tourn:quint cuffs that have a risk of both bladders inflating or deflating due to a leak between them. This could lead to improper blood flow control during medical procedures. Read more at govinfonow.com/recall/66170-zimmer-tourniquet-cuff-recall-dual-bladder-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66170-zimmer-tourniquet-cuff-recall-dual-bladder-leak-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1356-2020

Cite this page

“Zimmer Tourniquet Cuff Recall: Dual Bladder Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66170-zimmer-tourniquet-cuff-recall-dual-bladder-leak-risk. Based on FDA recall #Z-1356-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1356-2020%22&limit=1).

Why it’s dangerous

The tourniquet cuff has two bladders that can leak between them. When one bladder is inflated or deflated, the leak may cause both bladders to move, potentially leading to improper blood flow control during surgery.

Who’s affected

Medical professionals using these tourniquet cuffs for surgery are most at risk. The recall affects specific lot numbers and item codes sold to hospitals and clinics.

How to tell if you have this one

Check for the item number 60708015200 on the cuff. Look for the lot number 27968701 or the UDI code (01)00889024377547 (17)230812(10)27968701 on the packaging.

  • Brand
    Zimmer
  • Product
    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the item number 60708015200 and lot number 27968701 on the tourniquet cuff.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 19 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Idaho, Illinois, Iowa, Louisiana, Massachusetts, Missouri, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Jan 3, 202012. FDA classified it Class II: Feb 25, 202023. Published in FDA’s Enforcement Report: Mar 4, 202034. FDA terminated the recall: Oct 30, 202042020
  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.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a potential leak risk, so it is not recommended for use until the remedy is applied.

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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-1356-2020 (January 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1356-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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