1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA device recall Z-0585-2026 · posted 2025-11-21 · Open, Classified
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Products may contain contamination, which may result in a darker or brown media color.
- Action taken
- On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JTZ
- Quantity affected
- 1,000 US, 280 ROW
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cypru
- Date initiated
- 2025-11-12
- Date posted
- 2025-11-21
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUELLER HINTON BROTH (K802957) | Gibco Laboratories Life Technologies, Inc. | 1980-12-22 |
| BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 (K790687) | Gibco Laboratories Life Technologies, Inc. | 1979-05-03 |