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Data refreshed September 30, 2026 · last 180 days

502recalls · last 30 days
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387FDA · last 30 days
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3,487in 180-day window

Maquet Cardiopulmonary Gmbh recalls

RecallSweep is tracking 3 recall notices naming Maquet Cardiopulmonary Gmbh in the last 180 days, issued by FDA. The most recent is dated September 23, 2026. They cover Medical Devices.

This page lists what the issuing agencies published. It is not a statement about Maquet Cardiopulmonary Gmbh beyond those notices — open each official notice for the authoritative detail.

Recall notices naming Maquet Cardiopulmonary Gmbh

3 recalls.

FDA Class II Medical Devices

Maquet Cardiopulmonary Gmbh: Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Affected quantity: 68371 units (1765 US, 66606 OUS)

Hazard
The packaging may not consistently maintain sterile barrier integrity.

Details
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;. Recall #Z-3144-2026, initiated 20260731. Voluntary: Firm initiated.

Products affected
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);

Recall status
Ongoing

Look up recall #Z-3144-2026 in the FDA enforcement database ↗ Permalink →
FDA Class II Medical Devices

Maquet Cardiopulmonary Gmbh: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Affected quantity: 185617 units (5926 US, 179691 OUS)

Hazard
The packaging may not consistently maintain sterile barrier integrity.

Details
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;. Recall #Z-3145-2026, initiated 20260731. Voluntary: Firm initiated.

Products affected
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);

Recall status
Ongoing

Look up recall #Z-3145-2026 in the FDA enforcement database ↗ Permalink →
FDA Class II Medical Devices

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

Affected quantity: 16697 units (492 USA, 16205 OUS)

Hazard
The packaging may not consistently maintain sterile barrier integrity.

Details
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;. Recall #Z-3146-2026, initiated 20260731. Voluntary: Firm initiated.

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

Recall status
Ongoing

Look up recall #Z-3146-2026 in the FDA enforcement database ↗ Permalink →

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