CA500 Epix Universal Clip Applier Product Usage: The Epix disposable… — Class II medical device recall Z-1329-2016
Terminated recall by Applied Medical Resources Corp, reported 2016-04-13, distributed nationwide. Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME
| Recall number | Z-1329-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2015-12-22 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-10-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, ES, FR, GB, GR, IE, IT, JP, NL, RU, TR |
| Quantity | 1,771 units |
| Lot numbers | 1231562 |
Product
CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Reason for recall
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
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-1329-2016. 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.