BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip — Class II medical device recall Z-2767-2020
Terminated recall by Boss Instruments, Ltd., reported 2020-08-12, distributed nationwide. The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the s
| Recall number | Z-2767-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boss Instruments, Ltd., Zion Crossroads, VA, United States |
| Recall initiated | 2020-06-26 |
| Classified | 2020-08-05 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2021-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, JP, KR, NZ, TW, ZA |
| Quantity | 96 devices |
| Reason classes | device malfunction |
| Lot numbers | 00351415, 00374008, 00383211, 00384765, 00418258, 00425391, 07702195, 08801812, 08802271, 08804204, 09900093, 09900383 |
| Model numbers | 50-2503, 51-2503 |
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.
Reason for recall
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
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-2767-2020. 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.