Use caution Medical device recall · FDA · Published November 20, 2020

Maquet HLS Set Advanced 5.0 Recall: Sterility Barrier Breaches Risk Infection

Maquet recalls HLS Set Advanced 5.0 models with product code 70105.2797 due to sterility barrier breaches that could cause infections during cardiac surgery.

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

🇺🇸 FDA recall #Z-0632-2021Medical device Maquet ›

Use caution until it’s fixed

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Take action

Contact the company

Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling its HLS Set Advanced 5.0 models (product code 70105.2797) because the sterile packaging may have been compromised, risking infections during cardiac surgery. This is serious for patients undergoing heart or lung support procedures. Read more at govinfonow.com/recall/63827-maquet-hls-set-advanced-5-0-recall-sterility-barrier-breaches.

Source Summary by GovInfoNow · govinfonow.com/recall/63827-maquet-hls-set-advanced-5-0-recall-sterility-barrier-breaches · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0632-2021

Cite this page

“Maquet HLS Set Advanced 5.0 Recall: Sterility Barrier Breaches Risk Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63827-maquet-hls-set-advanced-5-0-recall-sterility-barrier-breaches. Based on FDA recall #Z-0632-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0632-2021%22&limit=1).

Maquet Cardiovascular Us Sales, Llc recalled the HLS Set Advanced (Model BEQ-HLS 5050 USA) due to sterility barrier breaches, according to a Food and Drug Administration announcement on Nov. 20, 2020.

How to tell if you have it

Brand: Maquet
Product Name: HLS Set Advanced; Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0
Part Number: 70105.2797
Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152

The hazard

The FDA said the HLS Set Advanced is being recalled due to breaches in the product's sterility barrier.

Context

GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since Oct. 25, 2018. Other recent recalls of similar products include Medline Convenience Kits Recall (June 12, 2026), Medline ARTERIAL LINE INSERTION KIT Recall (June 12, 2026) and Medline IV Start Kits Recalled Due to Sterility Risk in Packaging (June 12, 2026).

How to tell if you have this one

Check for the model name BEQ-HLS 5050 USA or the product code 70105.2797 on the device packaging. The lot codes listed in the recall include specific numbers like 70127790 through 70136152.

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
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.

Recall number	Product, codes & lots	Quantity
Z-0632-2021	HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.; Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152	58,438 devices worldwide
Z-0633-2021	HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.; Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038	N/A

Based on the official FDA remedy

What to do — step by step

Check Device Packaging
Look for the model name BEQ-HLS 5050 USA or product code 70105.2797 on the device packaging.
Contact Manufacturer
Reach out to Maquet Cardiovascular US Sales, LLC for instructions on how to handle the device if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark,…” 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 terminated this recall 4 years after the firm started it.

Nov 20, 2020Firm started the recall
Dec 17, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report
Nov 7, 2024FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall is due to potential sterility breaches that could cause infections, not immediate physical injury risks.

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Link to this recall

<a href="https://govinfonow.com/recall/63827-maquet-hls-set-advanced-5-0-recall-sterility-barrier-breaches">Maquet HLS Set Advanced 5.0 Recall: Sterility Barrier Breaches Risk Infection (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-0632-2021 (November 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0632-2021 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.