CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Urine Collection Kit recalled by MEDLINE INDUSTRIES, LP

Medline Industries LP - Northfield is recalling Urine Collection Kit, distributed nationwide in the US. The recall was initiated on 23 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSKU 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

Quantity recalled626,305 Total Kits (US only)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0358-2025
FDA event ID: 95628
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 23 Oct 2024
FDA classified: 12 Nov 2024
Reported: 20 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

23 Oct 2024	Recall initiated by company
12 Nov 2024	Classified by FDA	+20 days
20 Nov 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581

Where it was distributed

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

Nationwide Alabama California Florida Georgia Illinois Kentucky Missouri Mississippi Montana Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 95628

This product is part of a recall event; the main page for the event is Lab Kit recalled by MEDLINE INDUSTRIES, LP.

Reported	Class	Recall	Company	Reason	Where
20 Nov 2024	CLASS II	Lab Kit recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	Urine Collection Vhc recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	Clean Catch Kit recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	UA KIT recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	Urine KIT recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	Urine Kit W/bd Cup recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide
20 Nov 2024	CLASS II	Urinalysis Kit recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide

More recalls from Medline Industries LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	Medline Industries LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	Medline Industries LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	Medline Industries LP - Northfield	Labeling Errors	FL, IL

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