Recall Z-0370-2025
Stryker Corporation · initiated October 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703-046-002
Codes / lots: GTIN: 07613327379488 Lot Numbers: 53864143 57458172 58761873 63837701 64258041 65777003 66126554 66751061 68311144 54406823 57458173 58761874 63837702 64258042 65777004 66487383 67200500 68311145 54406824 57458174 60308898 63866394 64258044 65954742 66487384 67200501 68672590 54406825 57458175 60308899 63866395 64850548 65954743 66487385 67200502 68728239 54406826 57694644 62291709 64052771 64850549 65954744 66487386 67715714 68728240 54406827 57733684 62377382 64112622 64968511 65954745 66751059 67787217 54406828 58009712 62537206 64112623 64968512 66126553 66751060 68200024
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
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 of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. On behalf of Stryker, we thank you sincerely for your help and support in completing this action and regret any inconvenience that may be caused. We would like to reassure you that Stryker is committed to ensuring that only conforming devices, meeting our high internal quality standards and your expectations, remain on the market. If you have any questions about this matter, contact Stryker Instruments recall team directly by calling (269) 290-0524 or email at Instruments.Recalls@stryker.com. A Medical Device Recall Expansion notification letter dated 9/2/25 was sent to customers. Additional Lots A total of 47 lot numbers across two catalog numbers are listed below. Distribution dates in scope range from 03/29/2023 05/17/2024. Actions Needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return a new copy of 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 re
Details
- Recall number
- Z-0370-2025
- Initiated
- October 4, 2024
- Posted by FDA
- November 13, 2024
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 403,730 eaches
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
- Recalling firm
- Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0365-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0366-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0367-2025 Class II | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0368-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |
| Z-0369-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button -…There is a potential for the product to activate without manual input when plugged into a power source or… | 10/04/2024Open, Classified |