Use caution Medical device recall · FDA · Published May 18, 2023

Maquet QUADROX -i Neonatal Oxygenator Recall: Packaging Pinholes Risk Infection

Maquet recalls QUADROX -i neonatal oxygenators with packaging pinholes that could allow contamination. Affected units may cause infection or sepsis if sterile barrier is compromised.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1660-2023Medical device Maquet Medical Systems ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling neonatal oxygenators used during heart and lung surgery because packaging may have tiny pinholes invisible to the naked eye. These pinholes could let non-sterile materials enter the packaging, risking infection or sepsis for babies. Read more at govinfonow.com/recall/58165-maquet-quadrox-i-neonatal-oxygenator-recall-packaging-pinholes-risk-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/58165-maquet-quadrox-i-neonatal-oxygenator-recall-packaging-pinholes-risk-infection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1660-2023

Cite this page

“Maquet QUADROX -i Neonatal Oxygenator Recall: Packaging Pinholes Risk Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58165-maquet-quadrox-i-neonatal-oxygenator-recall-packaging-pinholes-risk-infection. Based on FDA recall #Z-1660-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2023%22&limit=1).

The FDA announced on May 18, 2023, that Maquet Medical Systems USA is recalling QUADROX -i Neonatal Oxygenators due to packaging pinholes that compromise sterility. The agency stated the recall is voluntary and ongoing.

How to tell if you have it

Brand: Maquet Medical Systems
Product: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item No.: HMO 10000-USA 701070412
Model Item No.: HMO 11000-USA 701070416
UDI: 4058863154473
UDI: 4058863154558
Lots: All lots

The hazard

Context

GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Recent brand recalls include the April 15, 2024, Maquet Cardiohelp-i System Recall for excessive patient leakage current and the Jan. 16, 2024, Maquet HLS Set Advanced 5.0 Recall for risk of infection from compromised sterile barrier. Other recent recalls of similar products include the July 31, 2026, Maquet Percutaneous Insertion Kit (PIK) Guidewire 150 cm Recall and the June 12, 2026, Medline Convenience Kits Recall.

How to tell if you have this one

Check for model numbers HMO 10000-USA (701070412) or HMO 11000-USA (701070416) on the packaging. These units were sold with specific serial codes and are part of the recall.

Brand
Maquet Medical Systems
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide domestic distribution

Recall number	Product, codes & lots	Quantity
Z-1655-2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388; Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots	0 (US)
Z-1656-2023	QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859; Model Item No. UDI-DI HMOD 70000-USA 701067840 4058863019000 BEQ-HMOD70000-USA 701067859 4058863019024	24,250 (US)
Z-1657-2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895; Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots	1,784 (US)
Z-1658-2023	QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330; Model Item No. UDI-DI BEQ-HMOD30000-USA 701070397 4058863154435 BEQ-HMOD30000-USA 701050330 4037691670164 All lots	5,022 (US)
Z-1659-2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829; Model Item No. UDI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 BEQ-HMO 71000-USA 701067829 4058863017372 All lots	0 (US)
Z-1660-2023	QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416; Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots	0 (US)
Z-1661-2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445; Model Item No. UDI VKMO 10000-USA 701070441 4058863153889 VKMO 11000-USA 701070445 4058863153889 All lots	0 (US)
Z-1662-2023	QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating; Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 N/A BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 N/A HMO 51100-USA 701067938 N/A HMO 70100-USA 701067874 N/A HMO 71100-USA 701067886 N/A All lots	0 (US)

Based on the official FDA remedy

What to do — step by step

Check Packaging for Pinholes
Look for small pinholes in the packaging that might not be visible to the naked eye.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide domestic distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 20 days after the firm started it.

May 18, 2023Firm started the recall
May 30, 2023FDA classified it Class II
Jun 7, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Maquet Medical Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/58165-maquet-quadrox-i-neonatal-oxygenator-recall-packaging-pinholes-risk-infection">Maquet QUADROX -i Neonatal Oxygenator Recall: Packaging Pinholes Risk Infection (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1660-2023 (May 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1660-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.