Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle… — Class II medical device recall Z-0543-2018
Terminated recall by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, reported 2018-02-14, distributed nationwide. BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above re
| Recall number | Z-0543-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, Hauppauge, NY, United States |
| Recall initiated | 2017-06-27 |
| Classified | 2018-02-06 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 5 cases |
| Reason classes | foreign material |
| Model numbers | 985 |
| Expiration dates | 2018-02-20 |
Product
Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
Reason for recall
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
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-0543-2018. 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.