Use cautionMedical device recall · FDA · Published June 18, 2020
Maquet Holder HKHZ 19 Recall: Risk of Oxygenator Not Securing Properly
Maquet recalls Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD neonatal/pediatric oxygenators due to potential failure to securely hold oxygenators during use. Affected units have lot number 70128207.
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
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 Holder HKHZ 19 accessories for neonatal and pediatric oxygenators because they may not securely hold the oxygenator during use. This could lead to the oxygenator becoming loose or dislodged, which might cause injury to the patient. Read more at govinfonow.com/recall/64958-maquet-holder-hkhz-19-recall-risk-of-oxygenator-not-securing.
“Maquet Holder HKHZ 19 Recall: Risk of Oxygenator Not Securing Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64958-maquet-holder-hkhz-19-recall-risk-of-oxygenator-not-securing. Based on FDA recall #Z-2780-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2780-2020%22&limit=1).
Maquet Cardiovascular US Sales, LLC recalled Holder HKHZ 19 (Model 701047495) for use with Quadrox-i and Quadrox-iD Neonatal/Pediatric Oxygenators on June 18, 2020. The U.S. Food and Drug Administration announced the Class II recall due to a sterility barrier breach risk in lot 70128207.
How to tell if you have it
Brand: Maquet
Product: Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators
Model Number: 701047495
Lot Number: 70128207
The hazard
The FDA stated that the Holder may not always snap and securely hold the oxygenator as intended. This defect affects lot number 70128207 of the product.
Context
GovInfoNow's records show Maquet Cardiovascular US Sales, LLC has had 14 other recalls on record since October 25, 2018. Other recent recalls include the Maquet HLS Set Advanced 7.0 recall (November 20, 2020) for sterility barrier breaches and the Maquet BMU 40 Blood Monitor recall (September 30, 2020) for PCBA short creepage risk. Similar recent recalls of medical devices include the Merit Medical Allwell Angioplasty Pack recall (December 4, 2025) and the Maquet PowerLED 300 Concealed Lighting System recall (August 7, 2026).
How to tell if you have this one
Check if your Holder HKHZ 19 has model number 701047495 and lot number 70128207. This product is used with Quadrox-i or Quadrox-iD neonatal/pediatric oxygenators.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify your Holder HKHZ 19 has model number 701047495 and lot number 70128207.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Ohio, Pennsylvania, South Carolina.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2780-2020 (June 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2780-2020 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.