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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Medline Medical Specimen and Urine Collection Kits Recalled for Sterility Issue

Agency Publication Date: November 12, 2024
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Summary

Medline Industries, LP is recalling approximately 626,305 Medical Specimen and Urine Collection Kits, including Clean Catch, Lab, and Urinalysis kits. The specimen containers included in these kits are labeled as sterile but have been identified as being non-sterile. Using these containers can lead to inaccurate test results, which may result in patients receiving unnecessary medical treatment or staying in the hospital longer than needed. No injuries have been reported in connection with this issue.

Risk

A non-sterile specimen container can contaminate medical samples before they are tested. This contamination may lead to false diagnostic results, potentially causing doctors to provide treatment for conditions a patient does not have or extending hospital stays while trying to determine the correct diagnosis.

What You Should Do

  1. This recall affects several Medline kits, including Clean Catch Kit, Lab Kit, UA Kit, and Various Urine Collection Kits under multiple SKUs.
  2. Identify if you have an affected kit by checking the SKU and lot number on the outer packaging. Affected SKUs include DYKM1833A, DYLAB1018, DYKM1690A, DYLAB1021, DYKM1848A, DYKM2005, DYKM2151, DYLAB1004, DYLAB1004A, DYLAB1006, DYLAB1012, DYLAB1016, DYKM1845, and DYLAB1001A. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled products immediately.
  4. Contact the manufacturer, Medline Industries, LP, or your medical distributor to arrange for a return, replacement, or correction of the kits.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Clean Catch Kit
Model / REF:
DYKM1833A
Lot Numbers:
19LAA531
20BAA260
21KBJ974
22JBK243
22LBJ966
23BBU789
23FBN998
23HBW916
23IBH024
24CBE580
24DBT234
24GBA986
24GBL321
UDI:
40193489240697
10193489240696

Component No. 503581

Product: Lab Kit
Model / REF:
DYLAB1018
Lot Numbers:
24IMC246
UDI:
40195327088393
10195327088392

Component No. 503581

Product: UA KIT
Model / REF:
DYKM1690A
Lot Numbers:
19KAA457
19LAB178
20FAB341
20IAA286
20WBC414
21CBK056
21EBG180
21HBC490
21KBB192
22ABJ687
22DBO057
22GBO519
22IBB016
22LBC924
23BBN989
23EBF212
23GBA753
23IBD142
23LBJ724
24BBI191
24FBC575
24GBX259
UDI:
40193489744201
10193489744200

Component No. 503581

Product: URINALYSIS KIT 4
Model / REF:
DYLAB1021
Lot Numbers:
22FBK384
22GBO520
UDI:
40195327109784
10195327109783

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYKM1848A)
Model / REF:
DYKM1848A
Lot Numbers:
19LAA062
19LAA679
19LAB089
20AAA248
20AAA946
UDI:
40193489228145
10193489228144

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYKM2005)
Model / REF:
DYKM2005
Lot Numbers:
21ABL580
21DBG554
21JBC048
21JBE414
21JBM540
21KBK233
21LBJ354
21LBJ398
UDI:
40193489475549
10193489475548

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYKM2151)
Model / REF:
DYKM2151
Lot Numbers:
24EMG654
24IMA511
UDI:
40195327132126
10195327132125

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYLAB1004)
Model / REF:
DYLAB1004
Lot Numbers:
20KBQ534
21ABL545
21IBC805
21JBN917
21JBX167
21KBN889
UDI:
40193489438223
10193489438222

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYLAB1004A)
Model / REF:
DYLAB1004A
Lot Numbers:
22GMH357
22IMG479
UDI:
40195327216680
10195327216689

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYLAB1006)
Model / REF:
DYLAB1006
Lot Numbers:
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
UDI:
40193489863575
10193489863574

Component No. 503581

Product: URINE COLLECTION KIT (SKU DYLAB1012)
Model / REF:
DYLAB1012
Lot Numbers:
21LBR785
22BBG465
22EBU527
22FBC688
22JBK244
22KBG840
22LBB361
23CBH872
23CBP152
23EBF399
23GBC712
23HBQ555
23IBT131
23KBK764
24ABG515
24CBH845
24CBP719
24DBJ359
24EBR584
24HBK276
24IBJ812
UDI:
40195327044122
10195327044121

Component No. 503581

Product: URINE COLLECTION VHC
Model / REF:
DYLAB1016
Lot Numbers:
22HLA350
22HLB291
UDI:
40195327139941
10195327139940

Component No. 503581

Product: URINE KIT
Model / REF:
DYKM1845
Lot Numbers:
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
UDI:
40193489713993
10193489713992

Component No. 503581

Product: URINE KIT W/BD CUP
Model / REF:
DYLAB1001A
Lot Numbers:
22DBP031
UDI:
40193489383707
10193489383706

Component No. 503581

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95628
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical distributors
Manufactured In: United States
Units Affected: 8 products (626,305 Total Kits (US only))
Distributed To: Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.