CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button recalled
Stryker is recalling Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed, distributed nationwide in the US. The recall was initiated on 4 Oct 2024 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-0370-2025
- FDA event ID
- 95502
- Recalling firm
- Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2024
- FDA classified
- 13 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 4 Oct 2024 | Recall initiated by company | |
| 13 Nov 2024 | Classified by FDA | +40 days |
| 20 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, 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. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703-046-002
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Questions about this recall
Why was it 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
Which lots are affected?
GTIN: 07613327379488 Lot Numbers: 53864143 57458172 58761873 63837701 64258041 65777003 66126554 66751061 68311144 54406823 57458173 58761874 63837702 64258042 65777004 66487383 67200500 68311145 54406824 57458174 60308898 63866394 64258044 65954742 66487384 67200501 68672590 54406825 57458175 60308899 63866395 64850548 65954743 66487385 67200502 68728239 54406826 57694644 62291709 64052771 64850549 65954744 66487386 67715714 68728240 54406827 57733684 62377382 64112622 64968511 65954745 66751059 67787217 54406828 58009712 62537206 64112623 64968512 66126553 66751060 68200024
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
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.
Other products in this recall event
5 other products · FDA event 95502This product is part of a recall event; the main page for the event is Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil recalled | Stryker | Other | Nationwide | |
| CLASS II | Neptune SafeAir Smoke Evacuation Pencil Non coated Blade recalled | Stryker | Other | Nationwide | |
| CLASS II | Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil recalled | Stryker | Other | Nationwide | |
| CLASS II | Neptune SafeAir Smoke Evacuation Pencil Coated recalled by Stryker | Stryker | Other | Nationwide | |
| CLASS II | Neptune SafeAir Smoke Evacuation Pencil, Coated Blade recalled | Stryker | Other | Nationwide |
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