Neptune E-SEP recallZ-1807-2020 · Stryker Instruments Div. of Stryker Corporation · initiated Mar 26, 2020
Terminated
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Stryker Instruments Div. of Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Due to a distribution error, product from the affected lot was shipped expired.
FDA root cause category: Under Investigation by firm
What the company is doing
URGENT MEDICAL DEVICE RECALL notification letters dated 03/26/2020 were distributed to customers. Actions needed 1. Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any recalled 165mm Blade Electrodes. 2. Return the enclosed Business Reply Form (BRF) by email to [email protected] to confirm receipt of this notification and identify how many affected items are currently in your inventory. 3. Upon receipt of the completed BRF, Stryker will contact you to arrange for the return and replacement of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate. Please complete and sign this form. Email the completed form to [email protected].
Recall details
- Recall number
- Z-1807-2020
- Status
- Terminated
- Initiated by the company
- Mar 26, 2020
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 40 units
- Product code
- GEI
- FDA submissions
- K182354
- Distribution
- International distribution the country of Canada.
Product description
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) 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.
Code information (models, lots, serial numbers)
Lot 16240231, GTIN 07613327297799
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neptune E-SEP 0703-165-001Stryker Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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