Class 2 Device Recall Stryker

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0368-2025
• Recall Event ID: 95502
• 510(K)Number: K143145
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• 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
• Code Information: 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 59417841 61288890 63090874 64117263 64573562 65178942 66758641 V56951197 59417842 61288891 63090875 64117264 64573563 65178943 66758642 V58582358 59417843 61288892 63090876 64117265 64573564 65178944 66758643 V58582359 59417844 61288893 63090877 64117266 64604782 65784634 66758644 V58582360 59417845 61288895 63248661 64147006 64604783 65876788 66758645 V58582361 59692163 62016962 63292646 64247932 64604784 65876789 66947800 V58582362 59692164 62016963 63292647 64262541 64855487 65876790 66947801 V58582363 59692165 62016964 63292648 64262542 64855488 65876791 67017673 59692166 62016965 63292649 64262543 64855489 65876792 67017674 59692167 62016966 63292650 64262549 64855490 65961906 67325427
• Recalling Firm/ Manufacturer: Stryker Corporation; 1941 Stryker Way; Portage MI 49002-9711
• For Additional Information Contact: SAME; 269-800-1941
• Manufacturer 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: 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
• Quantity in Commerce: 1,996,010 eaches
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI