Centurion FMS Pak — Class II medical device recall Z-2407-2023
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-2407-2023 |
|---|---|
| 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 | 87,839 units |
| UPC / GTIN / UDI-DI | 00380650001337, 00380650001344, 00380650001382, 00380650001399, 00380657521920, 00380657521937, 00380657522002, 00380657522019, 00380657522026, 00380657522033, 00380657522163, 00380657522170, 00380657522453, 00380657529179, 00380657529186, 00380657531349, 00380657531356, 00380657531363, 00380657531592 |
| Lot numbers | 14WW0H, 14WW0J, 14WW0K, 14WW0P, 14WW0R, 14WW0V, 14WW0W, 14WW0X, 14WW17, 14WW1F, 14WW1H, 14WW1J, 14WW1L, 14WW1M, 14WW1R, 14WW1T, 14WW1V, 14WW1W, 14X6A9, 14X6AA, 14X6AC, 14X6AD, 14X6AE, 14X6C6, 14X6C7, 14X6C8, 14X6C9, 14X6CA, 14X6CC, 14X6CD, 14X6CE, 14X6CF, 14X6CH, 14X6CJ, 14X6CK, 14X6CL, 14X6CM, 14X6CN, 14X6CP, 14X6CR and 460 more |
| Model numbers | 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202, 8065752203, 8065752216, 8065752217, 8065752245, 8065752917, 8065752918, 8065753134, 8065753135, 8065753136, 8065753159 |
Product
Centurion 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-2407-2023. 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.