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 | Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification. |
| Product | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549. |
| Quantity | US: 14 cases |
| Distribution | PA, FL, VA |
| Initiated | 2016-11-15 |
| Classified | 2016-12-22 |
| Terminated | 2018-06-21 |
| Recall number | Z-0894-2017 |
| 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-0894-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75746/
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