Aesculap Sterile disposable fleece drape — Class II medical device recall Z-1449-2022
Terminated recall by Aesculap Implant Systems LLC, reported 2022-07-27, distributed in CA, CO, GA, IL, IN, KY, MI, NC…. Packaging seal integrity not validated resulting in a lack of sterility assurance.
| Recall number | Z-1449-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2019-10-01 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-06-06 |
| Distributed | CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA, WI |
| Quantity | 4,500 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 04038653067862 |
| Lot numbers | 52024524, 52097698, 52172460, 52249972, 52340448, 551953371 |
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Reason for recall
Packaging seal integrity not validated resulting in a lack of sterility assurance.
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-1449-2022. 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.