Class 2 Device Recall Stryker

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0365-2025
• Recall Event ID: 95502
• 510(K)Number: K143145
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000
• Code Information: UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 53863667 54409860 56319955 56945654 57699376 59053480 65178946 53863668 54409862 56319956 57699353 57699377 59053481 65178947 53863669 54409919 56319957 57699354 57699378 59053482 65178949 53863670 54409920 56319958 57699355 57699379 59053483 65347997 53863671 54409921 56319959 57699359 57699380 61288937 65784636 54403959 54409922 56319960 57699360 57699381 61288943 65784637 54403960 54409923 56319961 57699361 57699382 62825781 65784638 54403961 54409924 56892676 57699362 57805609 64117282 65784639 54403962 54409925 56892677 57699363 57805610 64477143 65876797 54403963 54409926 56892689 57699364 57805611 64477144 65961918 54403964 54409927 56932527 57699365 58320366 64477145 66133414 54403965 54533880 56932528 57699366 58514707 64855504 66275138 54409851 54533881 56932533 57699367 58766534 64855505 V53051139 54409852 54533882 56932534 57699368 58766535 64855515 V53051140 54409853 54533883 56945645 57699369 58766536 64855516 V53267506 54409854 54533884 56945646 57699370 58766539 64973261 V53526100 54409855 54654973 56945647 57699371 58766540 64973262 V53708277 54409856 54665296 56945648 57699372 58791419 64973263 V53708278 54409857 56319952 56945651 57699373 59053477 64973266 V53934891 54409858 56319953 56945652 57699374 59053478 64973267 V53934892 V53934893 Additional Lot Numbers: 64262566 66387346 66599251 66758654 67377504 67652611 67794514 64973268 66387347 66705549 66758655 67377505 67652612 68735135 65178952 66387348 66705550 67017675 67377506 67652613 68735136 65178953 66387349 66758652 67017676 67481713 67794512 68735137 66387345 66599250 66758653 67207470 67652610 67794513 68735138
• 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: 1,120,860 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