Legion FMS Pak — Class II medical device recall Z-2409-2023
Ongoing recall by Alcon Research, LTD., reported 2023-08-23, distributed nationwide. Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening wi
| Recall number | Z-2409-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LTD., Sinking Spring, PA, United States |
| Recall initiated | 2023-06-28 |
| Classified | 2023-08-16 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, AW, BB, BD, BE, BG, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LU, LV, MA, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 2,628 units |
| UPC / GTIN / UDI-DI | 00380657531646, 00380657531653, 00380657531660 |
| Lot numbers | 14YTR7, 153UW1, 156YMH, 157R2M |
| Model numbers | 8065753164, 8065753165, 8065753166 |
Product
Legion FMS Pak
Reason for recall
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
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-2409-2023. 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.