Class 2 Device Recall Stryker

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0366-2025
• 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 Rocker-Switch, 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. Catalog Number: 0703-047-002
• Code Information: GTIN: 07613327379471 Lot Numbers: 53700305 53864207 53864241 53864247 60308905 62012084 64112630 65342955 53700306 53864212 53864243 53864248 60308906 62291715 64112631 65869470 53700307 53864213 53864244 53864249 60308907 62291717 64142443 65869471 53700308 53864214 53864245 53864257 61283868 62821201 64968515 65954806 53864205 53864219 53864246 60308904 61283869 64112629 64968516 66005707 53864206 Additional Lot Numbers: 64917537 65342956 66487443 67787272 67840867 68672644 64917538 66487442 67787271 67840866 67840868 68672645
• 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: 295,760 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