Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GYRUS ACMI Recalled by Gyrus Medical, Inc Due to Due to an anomaly in the packaging process,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gyrus Medical, Inc directly.
Affected Products
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.
Quantity: 5520 US, 40 OUS
Why Was This 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.
Where Was This Sold?
This product was distributed to 22 states: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA, MI, MS, NJ, NY, NC, OH, PA, SC, TN, UT, WA
About Gyrus Medical, Inc
Gyrus Medical, Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report