LapSac Introducer — Class II medical device recall Z-2314-2017
Terminated recall by Cook Inc., reported 2017-06-14, distributed nationwide. COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do no
| Recall number | Z-2314-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-05-01 |
| Classified | 2017-06-07 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2019-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CR, DE, ES, FI, FR, GB, HK, IE, IN, IT, LT, LV, MY, NL, RO, RU, SA, SG |
| Model numbers | G16500, J-LSI-102500 |
Product
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Reason for recall
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
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-2314-2017. 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.