BD FACS Universal Loader — Class III medical device recall Z-2598-2018
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2018-08-08, distributed in FL, KS, KY, MA, NJ, SD. The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader encl
| Recall number | Z-2598-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2018-05-16 |
| Classified | 2018-08-02 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2018-08-13 |
| Distributed | FL, KS, KY, MA, NJ, SD |
| Quantity | 8 devices |
| UPC / GTIN / UDI-DI | 00382906628794, 00662879000002 |
| Serial numbers | 2662879000001, 2662879000002, 2662879000003, 2662879000004, 2662879000009, 2662879000010, 2662879000011, 2662879000012 |
| Model numbers | 662879 |
Product
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.
Reason for recall
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
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-2598-2018. 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.