Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP… — Class II medical device recall Z-0147-2023
Ongoing recall by Edwards Lifesciences, LLC, reported 2022-11-09, distributed nationwide. Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in
| Recall number | Z-0147-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2022-10-06 |
| Classified | 2022-10-28 |
| Reported by FDA | 2022-11-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BS, CH, CL, CO, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HU, ID, IE, IL, IN, IR, IT, JP, KR, LB, MA, MT, MY, NI, NL, OM, PA, PH, PL, PT, QA, RO, SA, SE, SG, SK, TH, TN, TR, TW, ZA |
| Quantity | 26,560 units |
| UPC / GTIN / UDI-DI | 00690103205114, 00690103205121, 00690103205138 |
| Lot numbers | 410236FP, 410405FP, 63226301, 63226302, 63292038, 63292039, 63301401, 63374470, 63374472, 63412896, 63412897, 63412898, 63420115, 63420116, 63420117, 63420118, 63435504, 63435505, 63435506, 63451847, 63464730, 63475892, 63484862, 63488864, 63488865, 63501827, 63501828, 63523271, 63523275, 63544106, 63560673, 63560678, 63560687, 63567220, 63600417, 63611692, 63611693, 63611703, 63623904, 63623905 and 138 more |
| Model numbers | 410235FP, 410236FP, 410405FP |
Product
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Reason for recall
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
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-0147-2023. 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.