FDA Device recall Z-2221-2024
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
- FDA Device
- Class II
- completed
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101 by Aspen Surgical, citing the affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2221-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-06-03 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aspen Surgical |
| Distribution | US |
Product
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Reason
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Identifiers
| code_info | UDI-DI: 00840113214006; Lot Numbers: 389571, 389576, 390981, 390982 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2221-2024%22
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