Class II — Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
| Recalling firm | ROBERT BUSSE & CO., INC. |
|---|---|
| Registered facility | BUSSE HOSPITAL DISPOSABLES (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification. |
| Product | Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure |
| Quantity | 1037 in total |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-06-27 |
| Classified | 2018-02-06 |
| Terminated | 2020-07-27 |
| Recall number | Z-0545-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables (Z-0545-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78950/
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