GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm recallZ-0100-2015 · Gyrus Medical, Inc · initiated Aug 27, 2014
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gyrus Medical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.
Recall details
- Recall number
- Z-0100-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 27, 2014
- Posted by the FDA
- Oct 21, 2014
- Recalling firm
- Gyrus Medical, Inc
- Quantity
- 5520 US, 40 OUS
- Product code
- GEI
- FDA submissions
- K031078, K031081
- Distribution
- Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
Product description
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.
Code information (models, lots, serial numbers)
All product manufactured before July 28, 2014.
Other devices under the same FDA submission
2 devices cleared under K031078, K031081 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PK TECHNOLOGY 910000PKGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- PK TECHNOLOGY 3600PKGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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