Lower risk Medical device recall · FDA · Published July 22, 2022

Maquet Medical Systems Recalls HLS Set Advanced 5.0 for Sterility Risk

Maquet Medical Systems recalls HLS Set Advanced 5.0 (Part No. 70105.2797) due to potential sterility barrier breach. This could compromise product sterility for extracorporeal respiratory support.

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

🇺🇸 FDA recall #Z-1765-2022Medical device Maquet Medical Systems ›

Lower-risk recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Maquet Medical Systems is recalling their HLS Set Advanced 5.0 (Part No. 70105.2797) because of a potential breach in the sterility barrier. This could lead to compromised product sterility, which is especially concerning for medical devices used in extracorporeal respiratory support. Read more at govinfonow.com/recall/60323-maquet-medical-systems-recalls-hls-set-advanced-5-0-for.

Source Summary by GovInfoNow · govinfonow.com/recall/60323-maquet-medical-systems-recalls-hls-set-advanced-5-0-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1765-2022

Cite this page

“Maquet Medical Systems Recalls HLS Set Advanced 5.0 for Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60323-maquet-medical-systems-recalls-hls-set-advanced-5-0-for. Based on FDA recall #Z-1765-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1765-2022%22&limit=1).

The FDA announced on July 22, 2022, that Maquet Medical Systems USA is recalling the BEQ-HLS 5050 USA and HLS Set Advanced 5.0 due to a potential breach in the sterility barrier. The agency stated this defect may result in compromised product sterility.

How to tell if you have it

Brand: Maquet Medical Systems
Product names: BEQ-HLS 5050 USA; HLS Set Advanced 5.0
Part No.: 70105.2797
Lot code: 3000183908

The hazard

According to the FDA, the recall concerns a potential breach in the sterility barrier that may result in compromised product sterility. The firm initiated this voluntary recall after expanding it from a prior notice on November 6, 2020.

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 risk and the Jan. 16, 2024 Maquet BEQ-HLS 7050 Recall for compromised sterile barrier risk. Other recent recalls of similar products include Medline Convenience Kits sterility risks reported on Jan. 7, 2026.

How to tell if you have this one

Check for the model name 'HLS Set Advanced 5.0' and part number '70105.2797'. The device is used for extracorporeal respiratory and/or cardiovascular support in the CARDIOHELP System.

Brand
Maquet Medical Systems
Category
Medical device

FDA recall event · 4 products

All 4 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
Worldwide distribution - US Nationwide and the countries Canada and Australia.

Recall number	Product, codes & lots	Quantity
Z-1764-2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.; UDI-DI: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681	206 US; 48,960 Worldwide
Z-1765-2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.; UDI-DI: 04037691773513 Lot 3000183908	206 US; 48,960 Worldwide
Z-1766-2022	BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.; UDI-DI: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172	6,871 US; 18,670 worldwide
Z-1767-2022	BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.; UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522	6,871 US; 18,670 worldwide

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the model name 'HLS Set Advanced 5.0' and part number '70105.2797' on the device.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries Canada and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jul 22, 2022Firm started the recall
Sep 19, 2022FDA classified it Class II
Sep 28, 2022Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Maquet Medical Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/60323-maquet-medical-systems-recalls-hls-set-advanced-5-0-for">Maquet Medical Systems Recalls HLS Set Advanced 5.0 for Sterility 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-1765-2022 (July 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1765-2022 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.