Medline Recalls Non-Sterile Urinalysis Kit Specimen Containers
Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly cites 'prolonged hospitalization' as a potential consequence, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries, LP is recalling 626,305 units of the URINALYSIS KIT 4 (SKU DYLAB1021; Component No. 503581). The recall affects kits distributed nationwide in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA, and WA. The specific lots involved are 22FBK384 and 22GBO520.
The recall was initiated because the specimen containers included in these kits are labeled as sterile, but have been identified to be non-sterile. This labeling discrepancy presents a risk of harm to patients.
According to the FDA, the long-term consequences of using these non-sterile containers may include unnecessary treatment and/or prolonged hospitalization. Consumers and healthcare providers should check their inventory for the affected SKU and lot numbers and stop using these kits.
The recalled product
- Product
- URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Diagnostic Kits
- 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: 40195327109784 (Case)
- 10195327109783 (Ea) Lots: 22FBK384 22GBO520
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.
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