Maquet Medical Systems USA BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected
Products Sold
HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected
Maquet Medical Systems USA is recalling BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advance due to Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
Recommended Action
Per FDA guidance
On February 13, 2023, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed of the potential packaging issues and the associated risks to health. Customers were instructed to stop use and return all unused and unexpired affected product for credit. If customers have no alternative product, they may choose to continue use of the product, but they must perform a visual inspection of the primary packaging, checking for visible stress marks or damage to the packaging. If there are visible stress marks in the packaging, the customer should not use the product. Please note that there is a possibility that packaging defects may not be detectable by the naked eye. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026