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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Maquet Medical Systems USA: HLS Set Advanced Emergency Priming Line Recalled for Sterile Barrier Defect

Agency Publication Date: February 13, 2024
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Summary

Maquet Medical Systems is recalling 33,040 units of the Emergency Priming Line used with the HLS Set Advanced 5.0 and 7.0 heart-lung machines. The sterile barrier of these sets may be compromised due to sealing issues on the packaging bag. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this equipment defect.

Risk

A compromised sterile barrier can allow contaminants into the medical device, which may lead to serious medical conditions including inflammation, sepsis, or infection during use.

What You Should Do

  1. Check your inventory for HLS Set Advanced 5.0 (Model BEQ-HLS 5050 USA) with Product Code 70106.9077 and UDI-DI 04058863076355.
  2. Check your inventory for HLS Set Advanced 7.0 (Model BEQ-HLS 7050 USA) with Product Code 70106.9078 and UDI-DI 04058863080383.
  3. Verify if your sets match the following lot numbers: 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, 3000357174 (for 5.0 sets) or any of the over 80 specific lot numbers listed in the product description (for 7.0 sets).
  4. If you identify affected products, immediately contact Maquet Medical Systems USA or your healthcare facility's risk management department.
  5. Contact your healthcare provider or the manufacturer for further instructions and potential remedy or refund information.
  6. For additional questions, 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

๐Ÿ“‹Other Action

Healthcare provider or manufacturer notification

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

Affected Products

Product: HLS Set Advanced 5.0 (Model BEQ-HLS 5050 USA)
Model / REF:
BEQ-HLS 5050 USA
70106.9077
UPC Codes:
04058863076355
Lot Numbers:
3000301222
3000319782
3000327602
3000333098
3000352360
3000357174
Product: HLS Set Advanced 7.0 (Model BEQ-HLS 7050 USA)
Model / REF:
BEQ-HLS 7050 USA
70106.9078
UPC Codes:
04058863080383
Lot Numbers (82):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93849
Status: Active
Manufacturer: Maquet Medical Systems USA
Sold By: Maquet Medical Systems USA
Manufactured In: United States
Units Affected: 2 products (16520 worldwide; 6657 US)
Distributed To: Nationwide
Agency Last Updated: March 22, 2024

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 ยท 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.