CLASS II ONGOING Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
Beq-hls 5050 Usa recalled by Maquet Medical Systems U
Maquet Medical Systems USA is recalling Beq-hls 5050 Usa, distributed nationwide in the US. The recall was initiated on 22 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1765-2022
- FDA event ID
- 90740
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2022
- FDA classified
- 19 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- CPAP & Ventilators
Timeline
| 22 Jul 2022 | Recall initiated by company | |
| 19 Sep 2022 | Classified by FDA | +59 days |
| 28 Sep 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries Canada and Australia.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
UDI-DI: 04037691773513 Lot 3000183908
Where was it sold?
Worldwide distribution - US Nationwide and the countries Canada and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90740| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Beq-hls 7050 Usa recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Sterility | Nationwide | |
| CLASS II | Beq-hls 7050 Usa recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Sterility | Nationwide | |
| CLASS II | Beq-hls 5050 Usa recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Sterility | Nationwide |
More recalls from Maquet Medical Systems USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp-i System recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Packaging Defects | Nationwide |
| Device | CLASS II | Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |