CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil recalled
Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated - Designed for general, 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-0365-2025
- 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 Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - 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: 0703-047-000
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?
UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 53863667 54409860 56319955 56945654 57699376 59053480 65178946 53863668 54409862 56319956 57699353 57699377 59053481 65178947 53863669 54409919 56319957 57699354 57699378 59053482 65178949 53863670 54409920 56319958 57699355 57699379 59053483 65347997 53863671 54409921 56319959 57699359 57699380 61288937 65784636 54403959 54409922 56319960 57699360 57699381 61288943 65784637 54403960 54409923 56319961 57699361 57699382 62825781 65784638 54403961 54409924 56892676 57699362 57805609 64117282 65784639 54403962 54409925 56892677 57699363 57805610 64477143 65876797 54403963 54409926 56892689 57699364 57805611 64477144 65961918 54403964 54409927 56932527 57699365 58320366 64477145 66133414 54403965 54533880 56932528 57699366 58514707 64855504 66275138 54409851 54533881 56932533 57699367 58766534 64855505 V53051139 54409852 54533882 56932534 57699368 58766535 64855515 V53051140 54409853 54533883 56945645 57699369 58766536 64855516 V53267506 54409854 54533884 56945646 57699370 58766539 64973261 V53526100 54409855 54654973 56945647 57699371 58766540 64973262 V53708277 54409856 54665296 56945648 57699372 58791419 64973263 V53708278 54409857 56319952 56945651 57699373 59053477 64973266 V53934891 54409858 56319953 56945652 57699374 59053478 64973267 V53934892 V53934893 Additional Lot Numbers: 64262566 66387346 66599251 66758654 67377504 67652611 67794514 64973268 66387347 66705549 66758655 67377505 67652612 68735135 65178952 66387348 66705550 67017675 67377506 67652613 68735136 65178953 66387349 66758652 67017676 67481713 67794512 68735137 66387345 66599250 66758653 67207470 67652610 67794513 68735138
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 95502| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | |
| CLASS II | Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button recalled | Stryker | Other | Nationwide |
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