Tornado Embolization Microcoil — Class II medical device recall Z-1242-2022
Ongoing recall by Cook Incorporated, reported 2022-06-15, distributed nationwide. The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
| Recall number | Z-1242-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-05-05 |
| Classified | 2022-06-06 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 106,033 |
| UPC / GTIN / UDI-DI | 00827002082595, 00827002082618, 00827002083561, 00827002083578, 00827002099449, 00827002099456, 00827002129245, 00827002131026, 00827002131033, 00827002131040, 00827002131057, 00827002131064, 00827002131071, 00827002131088, 00827002474161, 00827002474178, 00827002474185, 00827002474192 |
| Lot numbers | 14144260, 14144261, 14149487, 14149518, 14151428, 14158173, 14158174, 14159387, 14159388, 14165309, 14173005, 14173006, 14173007, 14173009, 14174725, 14176799, 14176801, 14176802, 14176804, 14181258, 14181259, 14181260, 14181262, 14181263, 14183341, 14183343, 14183344, 14183345, 14183346, 14183347, 14185759, 14185762, 14185763, 14185764, 14185765, 14188217, 14188363, 14188366, 14195265, 14195266 and 460 more |
Product
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107
Reason for recall
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1242-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.