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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Maquet Cardiovascular, LLC: Express Chest Drains Recalled for Infection and Sepsis Risks

Agency Publication Date: January 12, 2024
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Summary

Maquet Cardiovascular is recalling 41,857 Express Chest Drains because they are pre-packaged with sterile water syringes that were previously recalled. If these chest drain devices are not kept in a strictly upright position, the patient may be exposed to infectious material from the syringe. This recall affects the Express Single (Product REF 4000-100N) and the Express Blood Recovery Unit (Product REF 4050-100N), which were distributed worldwide including across the United States. You should contact your healthcare provider or the manufacturer immediately for guidance on using these devices safely.

Risk

Exposure to infectious material from the recalled syringes can lead to serious health complications, including localized infections, abscesses, systemic sepsis, and potentially death.

What You Should Do

  1. Identify if you have the affected Express Single Collection unit (Product REF 4000-100N) by checking for UDI-DI 00650862115130 and any of the following 72 lot numbers: 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, or 466080.
  2. Identify if you have the affected Express Blood Recovery Unit (Product REF 4050-100N) by checking for UDI-DI 00650862115147 and any of the following 17 lot numbers: 499345, 498062, 496693, 495731, 494226, 492645, 492078, 490763, 487811, 490139, 489162, 487849, 483249, 470644, 468860, 467477, or 466952.
  3. If you are currently using one of these devices, ensure it is kept in an upright position at all times to minimize the risk of patient exposure to infectious material.
  4. Contact your healthcare provider or Maquet Cardiovascular, LLC at their Wayne, NJ office for specific instructions regarding the continued use or replacement of these pre-packaged systems.
  5. For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Healthcare provider or manufacturer consultation.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: EXPRESS SINGLE W/AC, Single Collection Drain
Model / REF:
REF 4000-100N
Lot Numbers (72):
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
Product: EXPRESS BRU W/AC, Blood Recovery Unit Drain
Model / REF:
REF 4050-100N
Lot Numbers:
499345
498062
496693
495731
494226
492645
492078
490763
487811
490139
489162
487849
483249
470644
468860
467477
466952

Product Images

Image 1: “Label of Express Dry Seal Chest Drain 4000 Single Collection”

Image 1: “Label of Express Dry Seal Chest Drain 4000 Single Collection”

Image 2: “Label of Express Dry Seal Chest Drain 4050 ATS Blood Recovery”

Image 2: “Label of Express Dry Seal Chest Drain 4050 ATS Blood Recovery”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93548
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Hospitals; Medical Supply Distributors
Manufactured In: United States
Units Affected: 2 products ((34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS); (7,501 cases/45,006 devices US); no OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.