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Lower risk Medical device recall · FDA · Published April 30, 2021

Medline Tissue Recovery Kit May Not Meet Sterility Standards

Medline recalls sterile tissue recovery kits that may not meet minimum sterility requirements for medical use. Affected kits have specific lot numbers and packaging details.

🇺🇸 FDA recall #Z-1841-2021Medical deviceMedline ›
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Recalling firmMedline Industries Inc3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling sterile tissue recovery kits that might not meet sterility standards. This could lead to infections if used in medical procedures. The kits were sold with specific lot numbers and packaging. Read more at govinfonow.com/recall/62628-medline-tissue-recovery-kit-may-not-meet-sterility-standards.

Source Summary by GovInfoNow · govinfonow.com/recall/62628-medline-tissue-recovery-kit-may-not-meet-sterility-standards · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1841-2021

Cite this page

“Medline Tissue Recovery Kit May Not Meet Sterility Standards.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62628-medline-tissue-recovery-kit-may-not-meet-sterility-standards. Based on FDA recall #Z-1841-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1841-2021%22&limit=1).

The FDA announced on April 30, 2021, that Medline Industries Inc is recalling Medline Tissue Recovery Instrument Sets because the devices may not meet the minimum required sterility assurance level. The agency issued recall number Z-1841-2021 for the Class II voluntary recall.

How to tell if you have it

  • Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A
  • UPC 10193489291186
  • Lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285

The hazard

The recalled Medline Tissue Recovery Instrument Sets may not meet the minimum required sterility assurance level. The products are convenience kits used to recover tissue for medical research, education, or transplantation.

Context

GovInfoNow's records show Medline Industries Inc has 48 other recalls on record since September 25, 2015. Other recent recalls of similar products include a Medline Chest Tube Kit recalled on July 21, 2022, for non-sterile tape in a sterile component, and a Medline Hand Sanitizer Foam recall on November 8, 2021, involving leaking containers.

How to tell if you have this one

Check for the lot numbers 21CDA959, 2:1BDB665, 21ADA390, and 20KDC285 on the packaging. The kits are packaged 3 per case and labeled as sterile for medical use.

  • Brand
    Medline
  • Product
    Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285 on the packaging.

Where it went and when

Where it was distributed

Distributed in Wisconsin.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: yesWIMichigan: 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: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: 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: “US Distribution to state of: WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Wisconsin.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Apr 30, 202112. FDA classified it Class II: Jun 9, 202123. Published in FDA’s Enforcement Report: Jun 16, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1841-2021 (April 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1841-2021 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