Endoscopic Kittner Blunt Dissecting Instrument — Class II medical device recall Z-2221-2024
Completed recall by ASPEN SURGICAL, reported 2024-07-03, distributed nationwide. The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integ
| Recall number | Z-2221-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | ASPEN SURGICAL, Caledonia, MI, United States |
| Recall initiated | 2024-06-03 |
| Classified | 2024-06-27 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,900 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00840113214006 |
| Lot numbers | 389571, 389576, 390981, 390982 |
| Model numbers | KT-9101 |
Product
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Reason for recall
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.
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-2221-2024. 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.