Agency classClass IIOur severity:High FDA (Devices)·Z-0360-2025·Announced 2024-11-20

Urine kit specimen containers recalled for non-sterile condition

Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device where injury has not been reported. The hazard—non-sterile specimen containers—poses significant contamination and infection risk, but no illnesses or hospitalizations have been documented in the source.

Plain-English summary

Medline Industries is recalling 626,305 URINE KIT units (SKU DYKM1845) distributed nationwide in 13 states due to a contamination issue affecting specimen containers.

The specimen containers included in the kits are labeled as sterile but have been identified as non-sterile. Using non-sterile collection containers can result in sample contamination, leading to false results, unnecessary treatment, or prolonged hospitalization.

The affected kits have been distributed to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. Patients and providers should stop using affected kits immediately. Healthcare facilities should verify inventory against provided lot numbers and UDI codes (Case: 40193489713993; Unit: 10193489713992).

The recalled product

Product: URINE KIT, SKU DYKM1845; Component No. 503581
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Specimen Collection
Hazard: non-sterile
contamination
Affected units: 626,305

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI: 40193489713993 (Case)
10193489713992 (Ea)

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Critical
Intubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
Severe
Medline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
High
Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
High
Surgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
High
Surgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03

Same hazard · non sterile