CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report

Beq-hls 5050 Usa recalled by Maquet Medical Systems U

Maquet Medical Systems USA is recalling Beq-hls 5050 Usa, distributed nationwide in the US. The recall was initiated on 13 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected

Quantity recalled10,587 units (US); 94,987 (worldwide)

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-1188-2023
FDA event ID: 91569
Recalling firm: Maquet Medical Systems USA, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 13 Feb 2023
FDA classified: 28 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: CPAP & Ventilators

Timeline

13 Feb 2023	Recall initiated by company
28 Feb 2023	Classified by FDA	+15 days
8 Mar 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

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or 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

BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Myanmar, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of North Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Republic of Korea, The Russian Federation, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.

Nationwide

Questions about this recall

Why was it recalled?

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

Which lots are affected?

HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected

Where was it sold?

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.

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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8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide