FDA Device recall Z-1978-2023
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572
- FDA Device
- Class II
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class II recall of Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572 by Wilson Cook Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1978-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-22 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wilson Cook Medical |
| Distribution | US |
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Reason
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.
Identifiers
| code_info | UDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1978-2023%22
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