Brand Name: Dako CoverStainer — Class II medical device recall Z-1919-2024
Ongoing recall by Agilent Technologies, reported 2024-06-05, distributed nationwide. There is the potential for the front plexiglass door of the automated slide processing system to break causing
| Recall number | Z-1919-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies, Loveland, CO, United States |
| Recall initiated | 2024-04-02 |
| Classified | 2024-05-29 |
| Reported by FDA | 2024-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, IE, IN, IQ, IT, JP, KE, KR, KW, LB, LV, MA, MY, NO, NZ, OM, PE, PL, PT, QA, RU, SA, SE, SK, TH, TR, TW, UA, VN |
| Quantity | 1,160 devices |
| Reason classes | device malfunction |
| Model numbers | CS10026, CS10026E, CS10030, CS10040 |
Product
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
Reason for recall
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1919-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.