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Lower risk Medical device recall · FDA · Published October 23, 2024

Medline Lab Kit Recalled: Non-sterile Specimen Containers Risk Infection

Medline Industries recalls Lab Kit SKU DYLAB1018 with non-sterile specimen containers that may cause infections requiring unnecessary treatment or hospitalization.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0355-2025Medical deviceMedline Industries ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline Industries is recalling Lab Kit SKU DYLAB1018 because the specimen containers are labeled as sterile but are actually non-sterile. This could lead to infections that require additional treatment or hospitalization. Read more at govinfonow.com/recall/53642-medline-lab-kit-recalled-non-sterile-specimen-containers-risk-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/53642-medline-lab-kit-recalled-non-sterile-specimen-containers-risk-infection · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0355-2025

Cite this page

“Medline Lab Kit Recalled: Non-sterile Specimen Containers Risk Infection.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53642-medline-lab-kit-recalled-non-sterile-specimen-containers-risk-infection. Based on FDA recall #Z-0355-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2025%22&limit=1).

The FDA announced on Oct. 23, 2024, that Medline Industries LP is recalling Lab Kits with SKU DYLAB1018 because specimen containers labeled as sterile are actually non-sterile. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Medline Industries
  • Product: Lab Kit
  • SKU: DYLAB1018
  • Component No.: 503581
  • UDI-DI (Case): 40195327088393
  • UDI-DI (Ea): 10195327088392
  • Lot: 24IMC246
  • Quantity: 626,305 Total Kits
  • Distribution: US Nationwide in AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA

The hazard

The specimen container included in the kits is labeled as sterile but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has had 119 other recalls on record since Oct. 22, 2021. Recent brand recalls include Medline medical kits with light failure in newborn resuscitation kits (July 25, 2025) and Medline Recalls 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: Risk of Contaminated Sterile Products (Jan. 7, 2026), and Medline Convenience Kits Recall: Sterile Packaging Risk (June 12, 2026).

How to tell if you have this one

Check for Lab Kit SKU DYLAB1018 with Component No. 503581. The kit was sold with lots 24IMC246.

  • Brand
    Medline Industries
  • Category
    Medical device
FDA recall event · 8 products

All 8 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
    US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Recall numberProduct, codes & lots
Z-0354-2025Clean Catch Kit, SKU DYKM1833A; Component No. 503581; UDI-DI: 40193489240697 (Case); 10193489240696 (Ea) Lots: 19LAA531 20BAA260 21KBJ974 22JBK243 22LBJ966 23BBU789 23FBN998 23HBW916 23IBH024 24CBE580 24DBT234 24GBA986 24GBL321
Z-0355-2025Lab Kit, SKU DYLAB1018; Component No. 503581; UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246
Z-0356-2025UA KIT, SKU DYKM1690A; Component No. 503581; UDI-DI: 40193489744201 (Case); 10193489744200 (Ea) Lots: 19KAA457 19LAB178 20FAB341 20IAA286 20WBC414 21CBK056 21EBG180 21HBC490 21KBB192 22ABJ687 22DBO057 22GBO519 22IBB016 22LBC924 23BBN989 23EBF212 23GBA753 23IBD142 23LBJ724 24BBI191 24FBC575 24GBX259
Z-0357-2025URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581; UDI-DI: 40195327109784 (Case); 10195327109783 (Ea) Lots: 22FBK384 22GBO520
Z-0358-2025URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581; SKU DYKM1848A - UDI/DI: 40193489228145 (Case), 10193489228144 (Ea) - Lots: 19LAA062 19LAA679 19LAB089 20AAA248 20AAA946; SKU DYKM2005 - UDI/DI: 40193489475549 (Case), 10193489475548 (Ea) - Lots: 21ABL580 21DBG554 21JBC048 21JBE414 21JBM540 21KBK233 21LBJ354 21LBJ398; SKU DYKM2151 - UDI/DI: 40195327132126 (Case), 10195327132125 (Ea) - Lots: 24EMG654 24IMA511; SKU DYLAB1004 - UDI-DI: 40193489438223 (Case), 10193489438222 (Ea) - Lots: 20KBQ534 21ABL545 21IBC805 21JBN917 21JBX167 21KBN889 SKU DYLAB1004A - UDI/DI: 40195327216680 (Case), 10195327216689 (Ea) - Lots: 22GMH357 22IMG479; SKU DYLAB1006 - UDI/DI: 40193489863575 (Case), 10193489863574 (Ea) - Lots: 21DBP497 21ELA493 21FLA001 21FLA001Z 21GLA397 21GLA835 22DLA811 22DLA903 22ELA725 22ELA923 22GLB140 22HLA173 22HLA458 22HLB334 22KLA089 22KLA161 23ALA267 23ALA943 23ALA960 23BLA520 23DLA028 23DLA896 23ELA259 23ELA755 23GLA515 23HLA543 23KLA012 24ALA101 24ALA799 24BLA337 24DLA479 24ELA438 24FLA307 24GLA156 24HLA576 24HLA989 24ILA230; SKU DYLAB1012 - UDI/DI: 40195327044122 (Case), 10195327044121 (Ea) - Lots: 21LBR785 22BBG465 22EBU527 22FBC688 22JBK244 22KBG840 22LBB361 23CBH872 23CBP152 23EBF399 23GBC712 23HBQ555 23IBT131 23KBK764 24ABG515 24CBH845 24CBP719 24DBJ359 24EBR584 24HBK276 24IBJ812
Z-0359-2025URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581; UDI/DI: 40195327139941 (Case), 10195327139940 (Ea), Lots 22HLA350 22HLB291
Z-0360-2025URINE KIT, SKU DYKM1845; Component No. 503581; UDI/DI: 40193489713993 (Case), 10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 22DMI870 22FMA088 22HMH213 22JMH449 22LMH860 23CMA518 23CMG948 23DMG087 23EMH568 23GMD322 23HME585 23IMG193 23KMD763 24AMD430 24CMA930 24CMD335 24DMA485 24FMF320 24GMJ197 24IME270
Z-0361-2025URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581; UDI/DI: 40193489383707 (Case), 10193489383706 (Ea), Lots 22DBP031
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Verify the product SKU and lot number to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Georgia, Illinois, Kentucky, Mississippi, Missouri, Montana, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 28 days after the firm started it.

1. Firm started the recall: Oct 23, 202412. FDA classified it Class II: Nov 12, 202423. Published in FDA’s Enforcement Report: Nov 20, 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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this kit?

The recall states long-term consequences may include unnecessary treatment and hospitalization, but no immediate serious injury risk is mentioned.

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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-0355-2025 (October 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0355-2025 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