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Use caution Medical device recall · FDA · Published February 11, 2025

Medline EYE PACK Kits Recalled Due to Potential Patient Health Risks

Medline recalls procedure kits labeled EYE PACK with specific pack numbers due to leaks and breakage risks that could harm patients during medical use.

🇺🇸 FDA recall #Z-1394-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling procedure kits labeled 'EYE PACK' with specific pack numbers because they may leak or break, posing a risk to patient health. This affects medical kits used for eye procedures. Read more at govinfonow.com/recall/52914-medline-eye-pack-kits-recalled-due-to-potential-patient-health.

Source Summary by GovInfoNow · govinfonow.com/recall/52914-medline-eye-pack-kits-recalled-due-to-potential-patient-health · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1394-2025

Cite this page

“Medline EYE PACK Kits Recalled Due to Potential Patient Health Risks.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52914-medline-eye-pack-kits-recalled-due-to-potential-patient-health. Based on FDA recall #Z-1394-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2025%22&limit=1).

The FDA announced on Feb. 11, 2025, that Medline Industries LP is recalling Medline procedure kits labeled as EYE PACK (Pack Number VAL038BSCLC) due to plastic syringes affected by a prior safety alert. The agency said the syringes may leak or break, posing a risk to patient health.

How to tell if you have it

  • Brand: Medline
  • Product: EYE PACK, Pack Number VAL038BSCLC
  • UPC: 10193489244441 (each), 40195327273133 (case)
  • Lot Number: 40193489244442
  • Units affected: 880

The hazard

The FDA said the kits contain plastic syringes affected by a Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since Oct. 22, 2021. Other recent recalls of similar products include Medline medical kits recalled for light failure in newborn resuscitation kits (July 25, 2025), Medline Foley Tray Kits with incorrect labeling risk (July 23, 2025), and Medline ReNewal Reprocessed St. Jude Catheters that may contain particulates (July 14, 2025). Other recent recalls of similar products include Medline Eye Kits recalled for risk of sterile packaging breach (June 12, 2026), Medline Ophthalmic Packs with Lidocaine due to an FDA quality issue (May 21, 2026), and Medline convenience kits recalled due to potentially contaminated components (July 10, 2026).

How to tell if you have this one

Check for kits labeled 'EYE PACK' with pack numbers VAL038BSCLC or specific lot numbers 40193489244442. These kits were sold in the U.S. for medical use.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-1393-2025Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098; 1) 10195327273132 (each) 40195327273133 (case), Lot Number 23GBK039Z456 kits
Z-1394-2025Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC; 1) 10193489244441 (each) 40195327273133 (case), Lot Number 40193489244442880 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Label

    Look for the pack number VAL038BSCLC or lot numbers 40193489244442 on the kit label.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Feb 11, 202512. FDA classified it Class II: Mar 18, 202523. Published in FDA’s Enforcement Report: Mar 26, 202532025
  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-1394-2025 (February 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1394-2025 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