CLASS II ONGOING Device recall · Reported 7 Jun 2023 · FDA Enforcement Report

Quadrox-i Pediatric, Oxygenator used during cardiopulmonary bypass recalled

Maquet Medical Systems USA is recalling Quadrox-i Pediatric, Oxygenator used during cardiopulmonary bypass, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

Quantity recalled0 (US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1655-2023
FDA event ID: 92006
Recalling firm: Maquet Medical Systems USA, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2023
FDA classified: 30 May 2023
Reported: 7 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

18 May 2023	Recall initiated by company
30 May 2023	Classified by FDA	+12 days
7 Jun 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

Where it was distributed

Nationwide domestic distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

Where was it sold?

Nationwide domestic distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 92006

This product is part of a recall event; the main page for the event is Quadrox -i Neonatal, Oxygenator used during cardiopulmonary bypass recalled.

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023	CLASS II	Quadrox -i Neonatal, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Quadrox-i Small Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Quadrox-i Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Quadrox-iD Pediatric, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Venous Hardshell Cardiotomy Reservoir recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023	CLASS II	Quadrox-iR, used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide

More recalls from Maquet Medical Systems USA

All 41

Reported	Class	Recall	Company	Reason	Where
22 May 2024Device	CLASS II	Cardiohelp-i System recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Packaging Defects	Nationwide
21 Feb 2024Device	CLASS II	Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled	Maquet Medical Systems USA	Sterility	Nationwide
21 Feb 2024Device	CLASS II	Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide

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