# FDA recall Z-3146-2026

> **Maquet Cardiopulmonary Gmbh** · Class II · device recall initiated 2026-07-31.

## Product

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);

## Reason for recall

The packaging may not consistently maintain sterile barrier integrity.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;

## Key facts

- **Recall number:** Z-3146-2026
- **Recalling firm:** Maquet Cardiopulmonary Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-31
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rastatt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3146-2026

## Citation

> MORVS. FDA recall Z-3146-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-3146-2026. Source: US FDA. Licensed CC0.

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