Reprocessed Xcel Bladeless Trocar — Class II medical device recall Z-0765-2017
Terminated recall by Stryker Sustainability Solutions, reported 2016-12-21, distributed nationwide. An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging
| Recall number | Z-0765-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2016-11-11 |
| Classified | 2016-12-14 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IL |
| Quantity | 40,476 devices |
| Reason classes | device malfunction |
| Model numbers | H12LP |
Product
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Reason for recall
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during 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-0765-2017. 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.