PKG — Class II medical device recall Z-0621-2015
Terminated recall by Stryker Endoscopy, reported 2014-12-24, distributed nationwide. The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision
| Recall number | Z-0621-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2014-11-17 |
| Classified | 2014-12-17 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BO, BR, CA, CH, CL, CN, CO, CR, DE, DZ, EC, ES, FR, GB, GR, GT, IN, IT, JO, JP, KR, KW, MA, MX, MY, NL, NZ, PE, PH, PL, PT, RO, SA, SE, TR, TW, VE, ZA |
| Quantity | 180,573 units |
| Reason classes | chemical contamination |
Product
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Reason for recall
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
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-0621-2015. 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.