LapSac Surgical Tissue Pouch — Class II medical device recall Z-1830-2015
Terminated recall by Cook Inc., reported 2015-07-01, distributed nationwide. Includes Information not stated in the intended use.
| Recall number | Z-1830-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2015-05-14 |
| Classified | 2015-06-24 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2016-09-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, CO, DK, IN, KR, MX, NZ |
| Quantity | 123,184 devices |
| Lot numbers | 054100, 054200, 054201, 054202, 054601, 054800, 4280701, 4283109, 4300816, 4310025, 4310027, 4337889, 4349570, 4349571, 4351774, 4351775, 4363194, 4373154, 4382550, 4382554, 4399199, 4399200, 4408864, 4434810, 4434813, 4434818, 4451573, 4475653, 4475654, 4475656, 4475658, 4499389, 4499391, 4503779, 4511698, 4511699, 4522443, 4530235, 4530237, 4536914 and 460 more |
Product
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
Reason for recall
Includes Information not stated in the intended use.
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-1830-2015. 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.