4 — Class II medical device recall Z-1199-2022
Terminated recall by Busse Hospital Disposables, Inc., reported 2022-06-08, distributed nationwide. Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposab
| Recall number | Z-1199-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Busse Hospital Disposables, Inc., Hauppauge, NY, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-05-28 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 99 units |
| UPC / GTIN / UDI-DI | 00849233017306 |
| Lot numbers | 2031076, 2130823 |
| Model numbers | B8121R1 |
Product
4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Reason for recall
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
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-1199-2022. 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.