Stop using now Medical device recall · FDA · Published January 16, 2024

Maquet BEQ-HLS 7050 Recalled: Compromised Sterile Barrier Risk

Maquet recalls BEQ-HLS 7050 USA HLS Set Advanced 7.0 with possible compromised sterile barrier causing infection risks. Affected units include specific product codes and lots. Stop using immediately to avoid infection.

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

🇺🇸 FDA recall #Z-1077-2024Medical device Maquet ›

Stop using this now

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Maquet is recalling certain BEQ-HLS 7050 USA heart-lung machine components due to a potential compromised sterile barrier that could lead to infection. This is serious because infections can cause sepsis or inflammation in medical procedures. Read more at govinfonow.com/recall/56309-maquet-beq-hls-7050-recalled-compromised-sterile-barrier-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56309-maquet-beq-hls-7050-recalled-compromised-sterile-barrier-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1077-2024

Cite this page

“Maquet BEQ-HLS 7050 Recalled: Compromised Sterile Barrier Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56309-maquet-beq-hls-7050-recalled-compromised-sterile-barrier-risk. Based on FDA recall #Z-1077-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1077-2024%22&limit=1).

The FDA announced on Jan. 16, 2024, that Maquet Medical Systems USA is recalling BEQ-HLS 7050 USA and HLS Set Advanced 7.0 heart-lung sets due to a compromised sterile barrier hazard. The agency said the defect may result in inflammation, sepsis, or infection.

How to tell if you have it

Brand: Maquet
Product names: BEQ-HLS 7050 USA, HLS Set Advanced 7.0
Product Code/Part Number: 70106.9078
Used with: CARDIOHELP heart-lung machine
UDI-DI: 04058863080383
Lot codes: 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487, 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440
Units affected: 16520 worldwide; 6657 US

The hazard

The FDA said the Emergency Priming Line component of the HLS Set may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

Context

GovInfoNow's records show Maquet Medical Systems USA has 14 other recalls on record since July 14, 2021. Other recent recalls of similar products include the Maquet Cardiohelp-i System Recall (April 15, 2024), the Maquet RotaFlow Centrifugal Pump Recall (Jan. 8, 2024), and the Maquet Bubble Sensor Recall (Dec. 28, 2023). Other recent recalls of similar products include the Medtronic GUNDRY Cannula Recall (April 21, 2026), the Medtronic DLP Retrograde Cannula Recall (April 21, 2026), and the Medtronic DLP Cannula Recall (April 21, 2026).

How to tell if you have this one

Check for the product code 70106.9078 on the BEQ-HLS 7050 USA HLS Set Advanced 7.0 used with CARDIOHELP heart-lung machines. Affected units include specific lot numbers listed in the recall notice.

Brand
Maquet
Category
Medical device

FDA recall event · 2 products

All 2 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 - US Nationwide distribution.

Recall number	Product, codes & lots
Z-1076-2024	Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.; UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 *Added 3/21/24* 3000333098, 3000352360, 3000357174
Z-1077-2024	BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.; UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 *Added 3/21/24* 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440

Recall number

Product, codes & lots

Z-1076-2024

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.; UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174

Z-1077-2024

BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.; UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the recalled BEQ-HLS 7050 USA HLS Set Advanced 7.0 components to prevent infection risks.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” 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 36 days after the firm started it.

Jan 16, 2024Firm started the recall
Feb 13, 2024FDA classified it Class II
Feb 21, 2024Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/56309-maquet-beq-hls-7050-recalled-compromised-sterile-barrier-risk">Maquet BEQ-HLS 7050 Recalled: Compromised 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-1077-2024 (January 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1077-2024 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.