Stryker Corporation Recall 95502
Description: 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
Stryker Corporation Recall 95502 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0365-2025 |
| Event ID | 95502 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia. |
| Quantity | 1,120,860 eaches |
| Recall Reason | 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 |
| Device Classification | 20241120 |
| Device Code Info | 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 |
| Center Classification Date | 20241113 |
| Recall Initiation Date | 20241004 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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