Recall Z-0370-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an
| Date | Nov 13, 2024 (initiated Oct 4, 2024) |
| Status | Open, Classified |
| Reason | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall Letter on 10/04/24 via Fed'X to Risk Manager, Materials Manager, OR Director. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt |
| Quantity | 403,730 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143145 | SafeAir Smoke Pencil Lina Medical Aps, Dec 4, 2014 |