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Lower risk Medical device recall · FDA · Published October 25, 2024

Medline Endo Kit Recall: Missing Sterile Packaging Info Risk

Medline is recalling Endo Kits with missing sterile packaging details. Affected kits may lack critical expiration and lot numbers on sterile packaging, risking improper use. Contact Medline for replacement.

🇺🇸 FDA recall #Z-0558-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling certain Endo Kits that may have missing sterile packaging information, including expiration dates and lot numbers. This could lead to improper use if the packaging details are not correctly identified. Read more at govinfonow.com/recall/53638-medline-endo-kit-recall-missing-sterile-packaging-info-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53638-medline-endo-kit-recall-missing-sterile-packaging-info-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0558-2025

Cite this page

“Medline Endo Kit Recall: Missing Sterile Packaging Info Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53638-medline-endo-kit-recall-missing-sterile-packaging-info-risk. Based on FDA recall #Z-0558-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0558-2025%22&limit=1).

The FDA announced on Oct. 25, 2024, that Medline Industries LP is recalling ENDO KITs and Medline Convenience Kits due to missing sterile and manufacturing lot numbers and expiration dates on packaging. This recall affects products distributed nationwide in New York.

How to tell if you have it

  • Brand: Medline
  • Product: ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469
  • Product: Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
  • Lot Number: 22EBD372
  • Distribution: US Nationwide distribution in the state of NY

The hazard

The identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. This information can be found on the outer box or zipper bag label.

Context

GovInfoNow's records show Medline Industries LP - Northfield has had 119 other recalls since Oct. 22, 2021. Recent Medline recalls include medical kits with light failure in newborn resuscitation kits (July 25, 2025) and Foley Tray Kits with incorrect labeling risk (July 23, 2025). Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), Medline Convenience Kits Recall: Sterile Packaging Risk (June 12, 2026), and Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (Jan. 7, 2026).

How to tell if you have this one

Check for the model number DYKE1577A and component number 57469. Look for lot number 22EBD372 on the outer box or zipper bag label.

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

What to do — step by step

  1. Check Packaging Details

    Look for expiration dates and lot numbers on the outer box or zipper bag label of the sterile packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Oct 25, 202412. FDA classified it Class II: Nov 26, 202423. Published in FDA’s Enforcement Report: Dec 4, 202432024
  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-0558-2025 (October 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0558-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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