Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10 — Class II medical device recall Z-1979-2023
Ongoing recall by Wilson-Cook Medical Inc., reported 2023-06-28, distributed nationwide. There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can resul
| Recall number | Z-1979-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wilson-Cook Medical Inc., Winston Salem, NC, United States |
| Recall initiated | 2023-05-22 |
| Classified | 2023-06-21 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 14,877 units |
| UPC / GTIN / UDI-DI | 00827002210493, 00827002213463 |
| Model numbers | G21049, G21346 |
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Reason for recall
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
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-1979-2023. 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.