Food, drugs, devices › Maquet Medical Systems USA
Device recall: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/o
FDA enforcement event 90740 is a device recall by Maquet Medical Systems USA of Wayne, NJ, initiated 22 Jul 2022 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Maquet Medical Systems USA has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Medical Systems USA, Wayne, NJ.
Reason for recall
"The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020)."
Distribution
"Worldwide distribution - US Nationwide and the countries Canada and Australia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1764-2022 | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. | 206 US; 48,960 Worldwide | Class II | Ongoing | 28 Sep 2022 |
| Z-1765-2022 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. | 206 US; 48,960 Worldwide | Class II | Ongoing | 28 Sep 2022 |
| Z-1766-2022 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. | 6,871 US; 18,670 worldwide | Class II | Ongoing | 28 Sep 2022 |
| Z-1767-2022 | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System. | 6,871 US; 18,670 worldwide | Class II | Ongoing | 28 Sep 2022 |
Context
Other enforcement events for Maquet Medical Systems USA
All 20 events for Maquet Medical Systems USA
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries Canada and Australia."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.