16F Dual Valved Splittable Sheath Introducer — Class I medical device recall Z-1577-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2026-04-01, distributed nationwide. 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may resu
| Recall number | Z-1577-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2026-02-13 |
| Classified | 2026-03-26 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, BZ, CA, CH, CL, CO, CR, DE, DO, EC, ES, FR, GB, GR, GT, HK, HN, ID, IE, IQ, IR, IT, JO, JP, KY, LV, MX, MY, NI, NL, PA, PE, PL, QA, SA, SE, SK, SV, TH, VE, VN, ZA |
| Quantity | 368,264 |
| UPC / GTIN / UDI-DI | 00884450522196 |
| Lot numbers | I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713 and 150 more |
| Model numbers | 16F, FCL-174-00/B, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670 and 167 more |
Product
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Reason for recall
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
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-1577-2026. 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.