Clean Catch Urine Kit Recalled Due to Improper Assembly
American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, indicating serious potential for harm. Although no illnesses or injuries are reported in the source material, the agency's classification mandates a minimum severity of 4 (Severe).
Plain-English summary
American Contract Systems, Inc. is recalling 274,400 Clean Catch Urine Kits (NS 178489, AHMU58A) distributed in Minnesota. The affected kits are from lots 891211, 737211, 699211, and 986221, with UDI-DI 00191072120557.
The recalled products were assembled off-site by individuals who may not have been properly trained. The FDA classified this as a Class I recall.
Consumers who have received or are using one of these kits should stop use of the affected lots and contact American Contract Systems, Inc. for information on replacement or return of the products.
The recalled product
- Product
- Clean Catch Urine Kit NS 178489, AHMU58A
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- assembly-defect
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 (4)
- UDI-DI: 00191072120557 Lots 891211
- 737211
- 699211
- 986221
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01