GYRUS ACMI — Class II medical device recall Z-1983-2013
Terminated recall by Gyrus Medical, Inc, reported 2013-08-28, distributed nationwide. On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study c
| Recall number | Z-1983-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Medical, Inc, Osseo, MN, United States |
| Recall initiated | 2013-07-24 |
| Classified | 2013-08-19 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CN, DE, IN |
| Quantity | 1,140 |
| Reason classes | labeling, sterility, packaging |
| Model numbers | 102290EB, 128971JB, 147428AC, 150080AC, 167021CC, 198596GC, 204439HC, 204451HC, 226730IC, 226742IC, 226743IC, 249022KC, 258624MC, 278142BD, 320659DD, 344712FD, 363953ID, 373761JD, 3740, 3740PK, 381809KD, 389095MD, 408020AE, 418231BE, 431894CE and 9 more |
Product
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Reason for recall
On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
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-1983-2013. 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.