HEMO-10 Hemospray Endoscopic Hemostat — Class II medical device recall Z-1746-2020
Terminated recall by Wilson-Cook Medical Inc., reported 2020-04-29, distributed nationwide. Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device i
| Recall number | Z-1746-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wilson-Cook Medical Inc., Winston Salem, NC, United States |
| Recall initiated | 2020-02-04 |
| Classified | 2020-04-17 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IQ, IS, IT, JO, JP, KR, KW, LB, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TN, TR, TT, VN |
| Quantity | 89,423 devices |
| Reason classes | packaging |
Product
HEMO-10 Hemospray Endoscopic Hemostat
Reason for recall
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
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-1746-2020. 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.