Urine Collection Kit Specimen Containers Recalled Due to Sterility Defect
Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.
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 FDA Class II recall involves a sterility defect in medical device specimen containers. Although no illnesses or injuries have been reported, the potential for contamination and resulting unnecessary treatment or hospitalization meets the criteria for High severity.
Plain-English summary
Medline Industries, LP is recalling the URINE KIT W/BD CUP (SKU DYLAB1001A, Component No. 503581). Approximately 626,305 kits have been distributed nationwide in the United States.
The specimen containers included in these kits are labeled as sterile but have been identified to be non-sterile. According to the manufacturer, long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
The affected kits were distributed to healthcare facilities across Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. Consumers and healthcare providers should discontinue use of affected kits and contact Medline Industries for guidance on replacement or proper disposal.
The recalled product
- Product
- URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- 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 (3)
- UDI/DI: 40193489383707 (Case)
- 10193489383706 (Ea)
- Lots 22DBP031
Distribution
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 →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- ModerateMedline Convenience Kits Recalled for Potential Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- SevereMedline Medical Device Kits Recalled for Potential Sterility Loss
FDA (Devices) · 2024-03-06
- CriticalMedline Surgical Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- SevereMedline Suction Catheter Kits Recalled for Potential Sterility Defects
FDA (Devices) · 2024-03-06
- SevereMEDLINE Medical Device Kits Recalled for Potential Sterility Issues
FDA (Devices) · 2024-03-06