Fogarty Arterial Embolectomy Catheters Model Number: 120602FP… — Class II medical device recall Z-0146-2023
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-0146-2023 |
|---|---|
| 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 | 715,620 units |
| UPC / GTIN / UDI-DI | 00690103201789, 00690103205084, 00690103205091, 00690103205107, 00690103205190, 00690103205206, 00690103205213, 00690103205220, 00690103205237, 00690103205244 |
| Lot numbers | 120403FP, 120404FP, 120803FP, 120803FSP, 120804FP, 120805FP, 120806FP, 120807FP, 63158527, 63227617, 63239464, 63239466, 63243604, 63243860, 63266182, 63266183, 63266184, 63266185, 63266186, 63266187, 63266275, 63266276, 63266279, 63266280, 63266281, 63266282, 63266283, 63266285, 63266286, 63281591, 63281593, 63281594, 63281611, 63281612, 63281613, 63281614, 63281615, 63281616, 63281617, 63281618 and 460 more |
| Model numbers | 120403FP, 120403FSP, 120404FP, 120602FP, 120803FP, 120803FSP, 120804FP, 120805FP, 120806FP, 120807FP |
Product
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
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-0146-2023. 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.