FDA Device recall Z-1751-2025
Pruitt Occlusion Catheter
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of Pruitt Occlusion Catheter by Lemaitre Vascular, citing during internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1751-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-11 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Reason
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Identifiers
| code_info | UDI-DI: 00840663101535, 00840663101542. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56. Lots…UDI-DI: 00840663101535, 00840663101542. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56. Lots not expired with the following prefix: POC, QPO, XPO. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1751-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.