CAIMAN DISP — Class II medical device recall Z-2497-2019
Terminated recall by Aesculap Implant Systems LLC, reported 2019-09-18, distributed nationwide. possibility of the sterility batch being insufficiently sterilized
| Recall number | Z-2497-2019 |
|---|---|
| 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 | 2019-08-07 |
| Classified | 2019-09-09 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | sterility |
| Lot numbers | 823B |
| Model numbers | PL731SU |
Product
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Reason for recall
possibility of the sterility batch being insufficiently sterilized
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-2497-2019. 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.