Use caution Medical device recall · FDA · Published February 13, 2023

Maquet BEQ-HLS 5050/7050 Recalls: Non-Sterile Risk

Maquet recalls BEQ-HLS 5050 and 7050 sets due to non-sterile packaging. Exposure may cause infection or sepsis. Affected units include specific product codes and batches.

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

🇺🇸 FDA recall #Z-1188-2023Medical device Maquet Medical Systems ›

Use caution until it’s fixed

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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Maquet is recalling two types of medical sets (BEQ-HLS 5050 and 7050) because their packaging might not be sterile. Using these sets could lead to infections or serious health issues like sepsis. Read more at govinfonow.com/recall/58906-maquet-beq-hls-5050-7050-recalls-non-sterile-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58906-maquet-beq-hls-5050-7050-recalls-non-sterile-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1188-2023

Cite this page

“Maquet BEQ-HLS 5050/7050 Recalls: Non-Sterile Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/58906-maquet-beq-hls-5050-7050-recalls-non-sterile-risk. Based on FDA recall #Z-1188-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1188-2023%22&limit=1).

The FDA announced on Feb. 13, 2023, that Maquet Medical Systems USA is recalling BEQ-HLS 5050 USA and HLS Set Advanced 5.0/7.0 sets due to insufficient evidence of packaging sterility. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Maquet Medical Systems
Product: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, UDI-DI 04058863076355
Product: BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078, UDI-DI 04058863080383
Part of the CARDIOHELP System
All lots/batches affected
Quantity: 10,587 units in the US; 94,987 worldwide

The hazard

The firm initiated a removal because of insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

Context

GovInfoNow's records show Maquet Medical Systems USA has had 14 other recalls since July 14, 2021. Recent recalls include a Jan. 16, 2024, recall of the Maquet BEQ-HLS 7050 for compromised sterile barrier risk and a Jan. 8, 2024, recall of the RotaFlow Centrifugal Pump for similar sterile barrier risks. Other recent recalls of similar products include a July 31, 2026, Maquet Percutaneous Insertion Kit (PIK) L Model 701054427 for sterile packaging risk and Jan. 7, 2026, and June 12, 2026, Medline Convenience Kits recalls for contaminated sterile products or sterile packaging breaches.

How to tell if you have this one

Check for product codes 70106.9077 (5.0 version) or 70106.9078 (7.0 version). These sets are part of the CARDIOHELP system used for critical care support.

Brand
Maquet Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Look for product codes 70106.9077 or 70106.9078 on the packaging or label.

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 of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China,…” 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 23 days after the firm started it.

Feb 13, 2023Firm started the recall
Feb 28, 2023FDA classified it Class II
Mar 8, 2023Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More Maquet Medical Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/58906-maquet-beq-hls-5050-7050-recalls-non-sterile-risk">Maquet BEQ-HLS 5050/7050 Recalls: Non-Sterile 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-1188-2023 (February 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1188-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.