Z-0358-2025Class II

URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component...

Name: Z-0358-2025 URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-23 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581 on 2024-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0358-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-23
Posted: 2024-11-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Product code: LRO General Surgery Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 23, 2024, the firm notified customers via Medical Device Recall letters sent through First Class Mail and Email. Customers were informed that the product is actually non-sterile and provided with the full list of impacted convenience kits. Once customers submit the recall response form, they will receive an over-label to place on affected kits, which instruct the user to remove the recalled component. Customers who would like a replacement specimen container may contact their sales representative. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 626,305 Total Kits (US only)
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0358-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0354-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0355-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0356-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0357-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0358-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0359-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0360-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0361-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)