CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report
Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of
Stryker Instruments Div. of Stryker is recalling Neptune E-sep Blade Electrode. The recall was initiated on 26 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1807-2020
- FDA event ID
- 85402
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2020
- FDA classified
- 28 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 26 Mar 2020 | Recall initiated by company | |
| 28 Apr 2020 | Classified by FDA | +33 days |
| 6 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a distribution error, product from the affected lot was shipped expired.
Product as listed by the FDA
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.
Where it was distributed
International distribution the country of Canada.
Questions about this recall
Why was it recalled?
Due to a distribution error, product from the affected lot was shipped expired.
Which lots are affected?
Lot 16240231, GTIN 07613327297799
Where was it sold?
International distribution the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Instruments Div. of Stryker
All 161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | Triton Canister System (finished part numbers FG recalled | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | SurgiCount+ System Application recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | KS, ME |
| Device | CLASS II | Stryker Zyphr Disposable Cranial Perforator recalled | Stryker Instruments Div. of Stryker | Foreign Material | Nationwide |
| Device | CLASS II | Telescopic Smoke Evac Pencil, PB, Coated, Product No. Shktspcl recalled | Stryker Instruments Div. of Stryker | Other | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |