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Neptune E-SEP recallZ-0366-2025 · Stryker Corporation · initiated Oct 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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 [email protected]. 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 [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A re

Recall details

Recall number
Z-0366-2025
Status
Open, Classified
Initiated by the company
Oct 4, 2024
Posted by the FDA
Nov 13, 2024
Recalling firm
Stryker Corporation
Quantity
295,760 eaches
Product code
GEI
FDA submissions
K143145
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95502).

Sources and updates

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