Class II — Boss Instruments, Ltd.
| Recalling firm | BOSS INSTRUMENTS, LTD. |
|---|---|
| Registered facility | BOSS INSTRUMENTS, LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. |
| Product | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris. |
| Quantity | 96 devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan. |
| Initiated | 2020-06-26 |
| Classified | 2020-08-05 |
| Terminated | 2021-07-20 |
| Recall number | Z-2767-2020 |
| 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 — Boss Instruments, Ltd. (Z-2767-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86040/
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