GYRUS ACMI — Class II medical device recall Z-0100-2015
Terminated recall by Gyrus Medical, Inc, reported 2014-10-29, distributed in AL, AZ, CA, FL, GA, HI, IA, IL…. Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may all
| Recall number | Z-0100-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Medical, Inc, Osseo, MN, United States |
| Recall initiated | 2014-08-27 |
| Classified | 2014-10-20 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-09-15 |
| Distributed | AL, AZ, CA, FL, GA, HI, IA, IL, IN, KY, MA, MI, MS, NC, NJ, NY, OH, PA, SC, TN, UT, WA |
| Countries outside the US | CN, ES, GB, IT |
| Reason classes | sterility, packaging |
| Model numbers | 3345, 3345PKPKS, 3640, 3640PK, 3844, 910010PK |
Product
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Reason for recall
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
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-0100-2015. 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.