Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers — Class II medical device recall Z-1521-2013
Terminated recall by Applied Medical Resources Corp, reported 2013-06-19, distributed nationwide. Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparos
| Recall number | Z-1521-2013 |
|---|---|
| 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 | 2013-05-01 |
| Classified | 2013-06-07 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, CA, CH, CL, CN, DE, DK, EC, ES, FI, FR, GB, GR, IE, IL, IN, IT, JO, KW, LB, MX, MY, NL, NZ, PE, PK, PL, PT, QA, RS, SA, SG, TR, TW, UY, ZA |
| Quantity | 127,305 units |
| Reason classes | device malfunction |
| Lot numbers | 1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248 and 77 more |
| Model numbers | 35CM, 5MM, C4130, C4140 |
Product
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Reason for recall
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;
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-1521-2013. 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.