Direct Drive Clip Applier CA090 — Class II medical device recall Z-1621-2016
Terminated recall by Applied Medical Resources Corp, reported 2016-05-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
| Recall number | Z-1621-2016 |
|---|---|
| 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 | 2016-04-01 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-02-07 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, EE, ES, FI, FR, GB, IE, IL, IN, IR, IT, JP, KR, KW, LB, MX, MY, NL, NO, NZ, QA, RS, SE, TH, UY, ZA |
| Quantity | 559,274 |
| Lot numbers | 1190181, 1197346, 1197347, 1197820, 1199151, 1199152, 1199421, 1200503, 1200914, 1201225, 1201735, 1201836, 1202109, 1202209, 1202967, 1202994, 1203027, 1203217, 1203344, 1203470, 1203748, 1204271, 1205019, 1205033, 1205245, 1205246, 1205249, 1205783, 1206845, 1206848, 1206923, 1207404, 1207472, 1207582, 1208179, 1208185, 1208188, 1208536, 1208641, 1208643 and 460 more |
Product
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Reason for recall
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
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-1621-2016. 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.