Reported Sep 23, 2026 · Ongoing
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Maquet Cardiopulmonary GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiopulmonary Gmbh · Kehler Str. 31 · Rastatt
Is this the product you have?
- Percutaneous Insertion Kit (PIK), dilator set L
- Model Numbers
701054427 (USA)701054427 (OUS)
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 Model Number (USA): 701054427 2 4037691746517UDI-DI: 4037691746517 3 Lot Numbers: 3000324476, 3000326923, 3000331200, 3000333822, 3000353373, 3000359477, 3000364060, 3000373784, 3000379853, 3000393466, 3000403658, 3000413596, 3000434593, 3000444270, 3000449725, 3000453328, 3000478750, 3000524542 4 Model Number (OUS): 701054427 5 4037691746517UDI-DI: 4037691746517 6 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 - Amount recalled
- 16697 units (492 USA, 16205 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The packaging may not consistently maintain sterile barrier integrity.
This product could cause temporary or reversible health problems — stop using it.
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