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

Maquet Blood Recovery Unit Recall: Risk of Infection if Not Upright

Maquet recalls blood recovery units with pre-packaged sterile water syringes that may cause infection if not kept upright. Affected units have specific lot numbers and serial codes.

🇺🇸 FDA recall #Z-0710-2024Medical deviceMaquet ›
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Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer

Maquet is recalling blood recovery units that come with pre-packaged sterile water syringes. If the unit isn't kept upright, patients could be exposed to infectious material, leading to infection, abscess, sepsis, or death. Read more at govinfonow.com/recall/56561-maquet-blood-recovery-unit-recall-risk-of-infection-if-not.

Source Summary by GovInfoNow · govinfonow.com/recall/56561-maquet-blood-recovery-unit-recall-risk-of-infection-if-not · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0710-2024

Cite this page

“Maquet Blood Recovery Unit Recall: Risk of Infection if Not Upright.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56561-maquet-blood-recovery-unit-recall-risk-of-infection-if-not. Based on FDA recall #Z-0710-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2024%22&limit=1).

The FDA announced on Dec. 13, 2023, that Maquet Cardiovascular, LLC is recalling the Express BRU W/AC Blood Recovery Unit because it may be pre-packaged with sterile water syringes subject to a separate recall, potentially exposing patients to infectious material. The agency classified this Class I recall as voluntary and firm-initiated.

How to tell if you have it

  • Brand: Maquet
  • Product: REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
  • UDI-DI: 00650862115147
  • Lots: 499345, 498062, 496693, 495731, 494226, 492645, 492078, 490763, 487811, 490139, 489162, 487849, 483249, 470644, 468860, 467477, 466952

The hazard

The hazard arises because the Express chest drains are pre-packaged with sterile water syringes that have been recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Other recent recalls of similar products include Medline Reprocessed Catheters Recall (May 15, 2026), Embosphere 500-700 Micrometer Syringe Recall (Aug. 10, 2026), and Medline Blood Culture Kits Recall (June 12, 2026).

How to tell if you have this one

Check for the product code REF 4050-100N, DRAIN, EXPRESS BRU W/AC. Look for lot numbers in the list: 499345, 498062, 496693, 495731, 494226, 492645, 492078, 490763, 487811, 490139, 489162, 487849, 483249, 470644, 468860, 467477, 466952.

  • 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 I
  • Status
    Ongoing
  • Distribution
    Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Recall numberProduct, codes & lotsQuantity
Z-0709-2024Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection; UDI-DI 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Z-0710-2024Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit; UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952(7,501 cases/45,006 devices US); no OUS
Based on the official FDA remedy

What to do — step by step

  1. Check Device Position

    Ensure the blood recovery unit is kept upright to prevent leakage of infectious material.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK” 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 42 days after the firm started it.

1. Firm started the recall: Dec 13, 202312. FDA classified it Class I: Jan 12, 202423. Published in FDA’s Enforcement Report: Jan 24, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

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

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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-0710-2024 (December 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0710-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA