Cannula and Seal — Class II medical device recall Z-1836-2015
Terminated recall by Stryker Sustainability Solutions, reported 2015-07-01, distributed nationwide. Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some
| Recall number | Z-1836-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2015-06-01 |
| Classified | 2015-06-25 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 147,351 |
| Reason classes | device malfunction |
| Model numbers | 1742132, 1786420, 1825271, 1891296, 2027905, 2163528, 2171826, 2175866, 2208579, 2222389, 2271560, 2271563, 2279303, 2295535, 2315316, 2954381, 2954628, 2954637, 2954778, 2957110, 2957134, 2958233, 2958246, 2969207, 2969426 and 259 more |
Product
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Reason for recall
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
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-1836-2015. 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.