FDA Device recall Z-3146-2026
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS)
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS) by Maquet Cardiopulmonary, citing the packaging may not consistently maintain sterile barrier integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3146-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Maquet Cardiopulmonary |
| Distribution | US |
Product
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Reason
The packaging may not consistently maintain sterile barrier integrity.
Identifiers
| code_info | Model Number (USA): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000…Model Number (USA): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000353373, 3000359477, 3000364060, 3000373784, 3000379853, 3000393466, 3000403658, 3000413596, 3000434593, 3000444270, 3000449725, 3000453328, 3000478750, 3000524542; Model Number (OUS): 701054427; UDI-DI: 4037691746517; Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333821, 3000333822, 3000341452, 3000349478, 3000353373, 3000356330, 3000359477, 3000364060, 3000370472, 3000373784, 3000379853, 3000387894, 3000389007, 3000393466, 3000395576, 3000403658, 3000411197, 3000413596, 3000418475, 3000434593, 3000438011, 3000441822, 3000444270, 3000449725, 3000453328, 3000461221, 3000466027, 3000468435, 3000471532, 3000478750, 3000485149, 3000489899, 3000501535, 3000508513, 3000518008, 3000524542, 3000525465, 3000526923, 3000534009, 3000539532, 3000541224; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Maquet Cardiopulmonary
- Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS)
FDA Device · Class II · 2026-09-23 · Maquet Cardiopulmonary - Bubble Sensor for 3/8" x 3/32" tubing
FDA Device · Class II · 2026-02-11 · Maquet Cardiopulmonary - Sprinter Cart/Sprinter Cart XL Infusion Pole
FDA Device · Class II · 2025-08-06 · Maquet Cardiopulmonary
All Maquet Cardiopulmonary recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3146-2026%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.