Z-1807-2020Class II

Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 -

Name: Z-1807-2020 Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 -
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2020-03-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2020-03-26 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2020-03-26. FDA classified it as Class II and gives the reason as "Due to a distribution error, product from the affected lot was shipped expired". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1807-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-26
Posted: 2020-04-28
Terminated: 2020-07-15
Recalling firm: Stryker Corp.
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Due to a distribution error, product from the affected lot was shipped expired.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 40 units
Distribution: International distribution the country of Canada.
Product codes and lots: Lot 16240231, GTIN 07613327297799

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1807-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1807-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-28

Product code GEI

K182354Class IISafeAir Telescopic Smoke PencilLina Medical Aps / cleared 2018-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)