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

Maquet QUADROX-i Pediatric Oxygenator Recall: Packaging Sterile Barrier Risk

Maquet recalls QUADROX-i Pediatric Oxygenators due to packaging defects that could compromise sterile barriers, risking infection. Affected units include specific model numbers and lots.

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

🇺🇸 FDA recall #Z-1641-2023Medical device Maquet Medical Systems ›

Use caution until it’s fixed

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product 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 QUADROX-i Pediatric Oxygenators used during heart surgery because packaging flaws might allow non-sterile materials to contact the device, increasing infection risk. This is serious for patients undergoing cardiopulmonary bypass procedures. Read more at govinfonow.com/recall/58175-maquet-quadrox-i-pediatric-oxygenator-recall-packaging-sterile-barrier-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58175-maquet-quadrox-i-pediatric-oxygenator-recall-packaging-sterile-barrier-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1641-2023

Cite this page

“Maquet QUADROX-i Pediatric Oxygenator Recall: Packaging Sterile Barrier Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58175-maquet-quadrox-i-pediatric-oxygenator-recall-packaging-sterile-barrier-risk. Based on FDA recall #Z-1641-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1641-2023%22&limit=1).

The FDA announced on May 18, 2023, that Maquet Medical Systems USA is recalling QUADROX-i Pediatric Oxygenators due to potential sterile barrier compromise. The hazard includes inflammation, infection, sepsis, and ischemia if the packaging is damaged.

How to tell if you have it

Brand: Maquet Medical Systems
Product: QUADROX-i Pediatric Oxygenator
Model/Item No.: HMO 30000-USA 701070384
Model/Item No.: HMO 31000-USA 701070388
UDI-DI: 4058863153681
UDI-DI: 4058863154299
Lots: All lots

The hazard

The recall cites two issues: an accessory improperly placed during packaging causing creases and damage to the sterile pouch, and packaging exhibiting holes, cracks, dents, or crushed areas. Both issues may compromise the sterile barrier, resulting in exposure to non-sterile product which may cause inflammation, infection, sepsis, and ischemia.

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 a compromised sterile barrier. Other recent recalls of similar products include the April 21, 2026 Medtronic GUNDRY Cannula Recall, the April 21, 2026 Medtronic DLP Cannula Recall, and the April 21, 2026 Medtronic DLP Retrograde Cannula Recall.

How to tell if you have this one

Check for model numbers HMO 30000-USA (701070384) or HMO 31000-USA (701070388) on the packaging. All lots of these models are affected.

Brand
Maquet Medical Systems
Category
Medical device

FDA recall event · 10 products

All 10 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
Domestic distribution nationwide.

Recall number	Product, codes & lots	Quantity
Z-1634-2023	HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840; UDI-DI: 04058863019000 All lots	8,670 (US)
Z-1635-2023	BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859; UDI-DI: 04058863019024 All lots	15,880 (US)
Z-1636-2023	BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905; UDI-DI: 04058863019079 All lots	1,784 (US)
Z-1637-2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895; Model Item no. UDI-DI HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots	0 (US)
Z-1638-2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823; Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 All lots	0 (US)
Z-1639-2023	BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829; UDI-DI: 4058863017372 All lots	0 (US)
Z-1640-2023	QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416; Model Item no. UDI-DI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots	0 (US)
Z-1641-2023	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-1642-2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445; Model Item No. UDI-DI VKMO 10000-USA 701070441 4058863153841 VKMO 11000-USA 701070445 4058863153889 All lots	0 (US)
Z-1643-2023	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 Condition
Inspect the packaging for creases, holes, cracks, or dents that might compromise the sterile barrier.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Domestic distribution nationwide.” 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 26, 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

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Link to this recall

<a href="https://govinfonow.com/recall/58175-maquet-quadrox-i-pediatric-oxygenator-recall-packaging-sterile-barrier-risk">Maquet QUADROX-i Pediatric Oxygenator Recall: Packaging Sterile Barrier Risk (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-1641-2023 (May 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1641-2023 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.