Recall Z-0368-2025
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, 70mm Blade, Push Button Switch - 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. Catalog Number: 0703-046-000
Codes / lots: GTIN: 07613327117202 Lot Numbers: 54409778 59692168 62016967 63292654 64324200 64855491 65961907 67325428 57699286 60313543 62016978 63292655 64324201 64855498 65961908 67377503 57738329 60313544 62296666 63632847 64324207 64855499 65961909 67481708 57738330 60313545 62296667 63632848 64324208 64855500 66012917 67481709 57738331 60313546 62296668 63632851 64354844 64855501 66012918 67481710 57738332 60313547 62382103 63632852 64354845 64973248 66133412 67481711 57738333 60313549 62382104 63842616 64354846 64973249 66387344 67481712 57738334 60834119 62382105 63842618 64354847 64973253 66494921 67652608 58014507 60834120 62678399 63842619 64354850 64973254 66494922 67652609 58014508 60834121 62678400 63842620 64354851 64973255 66494923 67722909 58014509 60834122 62678401 63871520 64477131 64973256 66494924 67794511 58014519 60834123 62678402 63871521 64477132 64973257 66494925 V56951192 58514679 60834124 62678403 63871522 64477135 64973258 66599248 V56951193 58514680 60834125 62678404 63871523 64477136 64973259 66599249 V56951194 59053422 61288888 63090872 63871524 64573557 64973260 66705547 V56951195 59053423 61288889 63090873 64117262 64573561 65178940 66705548 V56951196…
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-0368-2025
- Initiated
- October 4, 2024
- Posted by FDA
- November 13, 2024
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 1,996,010 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-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 |
| Z-0370-2025 Class II | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, 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 |