Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - 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: 0703-046-000
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
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
GTIN: 07613327117202 Lot Numbers: 54409778 59692168 62016967 63292654 64324200 64855491 65961907 67325428 57699286 60313543 62016978 63292655 64324201 64855498 65961908 67377503 57738329 60313544 62296666 63632847 64324207 64855499 65961909 67481708 57738330 60313545 62296667 63632848 64324208 64855500 66012917 67481709 57738331 60313546 62296668 63632851 64354844 64855501 66012918 67481710 57738332 60313547 62382103 63632852 64354845 64973248 66133412 67481711 57738333 60313549 62382104 63842616 64354846 64973249 66387344 67481712 57738334 60834119 62382105 63842618 64354847 64973253 66494921 67652608 58014507 60834120 62678399 63842619 64354850 64973254 66494922 67652609 58014508 60834121 62678400 63842620 64354851 64973255 66494923 67722909 58014509 60834122 62678401 63871520 64477131 64973256 66494924 67794511 58014519 60834123 62678402 63871521 64477132 64973257 66494925 V56951192 58514679 60834124 62678403 63871522 64477135 64973258 66599248 V56951193 58514680 60834125 62678404 63871523 64477136 64973259 66599249 V56951194 59053422 61288888 63090872 63871524 64573557 64973260 66705547 V56951195 59053423 61288889 63090873 64117262 64573561 65178940 66705548 V56951196 59417841 61288890 63090874 64117263 64573562 65178942 66758641 V56951197 59417842 61288891 63090875 64117264 64573563 65178943 66758642 V58582358 59417843 61288892 63090876 64117265 64573564 65178944 66758643 V58582359 59417844 61288893 63090877 64117266 64604782 65784634 66758644 V58582360 59417845 61288895 63248661 64147006 64604783 65876788 66758645 V58582361 59692163 62016962 63292646 64247932 64604784 65876789 66947800 V58582362 59692164 62016963 63292647 64262541 64855487 65876790 66947801 V58582363 59692165 62016964 63292648 64262542 64855488 65876791 67017673 59692166 62016965 63292649 64262543 64855489 65876792 67017674 59692167 62016966 63292650 64262549 64855490 65961906 67325427
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Recall record
- Recalling firm
- Stryker Corporation
- Product type
- Devices
- Recall number
- Z-0368-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Portage, MI
- Recall initiated
- 2024-10-04
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0368-2025 · Source: openFDA enforcement.