Pruitt Irrigation Occlusion Catheter — Class II medical device recall Z-1752-2025
Ongoing recall by LeMaitre Vascular, Inc., reported 2025-05-21, distributed nationwide. During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier)
| Recall number | Z-1752-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2025-04-11 |
| Classified | 2025-05-12 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HU, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PH, PL, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TT, TW, VE, VN, ZA |
| Quantity | 26,872 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00840663101559, 00840663101566, 00840663101573, 00840663101580, 00840663101597, 00840663101603 |
| Model numbers | 2102-09, E2102-09 |
Product
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Reason for recall
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
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-1752-2025. 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.