Maquet Medical Systems USA recalls

Maquet Medical Systems USA has 41 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 22 May 2024. 35 are still ongoing. The most frequent reason is sterility.

Total recalls41since 2012

Last 12 months0reported

Class I12% of total

Ongoing35latest 22 May 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 2%Class II 39 95%Class III 1 2%

Why maquet medical systems usa is recalled

Product types

By year

2024615%
20232459%
2022512%
202112%
201612%
201512%
201412%
201312%
201212%

Ongoing maquet medical systems usa recalls

35 active

Reported	Class	Recall	Company	Reason	Where
22 May 2024Device	CLASS II	Cardiohelp-i System recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Packaging Defects	Nationwide
21 Feb 2024Device	CLASS II	Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled	Maquet Medical Systems USA	Sterility	Nationwide
21 Feb 2024Device	CLASS II	Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bubble Sensor recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Device Malfunction	13 states

All maquet medical systems usa recalls, newest first

41 total

Reported	Class	Recall	Company	Reason	Where
22 May 2024Device	CLASS II	Cardiohelp-i System recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Packaging Defects	Nationwide
21 Feb 2024Device	CLASS II	Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled	Maquet Medical Systems USA	Sterility	Nationwide
21 Feb 2024Device	CLASS II	Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Bubble Sensor recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Device Malfunction	13 states
27 Dec 2023Device	CLASS III	Cardiohelp-i Heart Lung Support System recalled	Maquet Medical Systems USA	Packaging Defects	Nationwide
27 Dec 2023Device	CLASS II	Venous probe connection cable recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Temperature Abuse	Nationwide
20 Dec 2023Device	CLASS II	Cardiohelp-i Heart Lung Support System- A blood oxygenation recalled	Maquet Medical Systems USA	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS I	Cardiohelp Emergency Drive, Part Numbers recalled	Maquet Medical Systems USA	Other	Nationwide
15 Nov 2023Device	CLASS II	Cardiohelp-i, blood oxygenation recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Device Malfunction	Nationwide
7 Jun 2023Device	CLASS II	Hmod 70000-Usa/Quadrox-iD Adult recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Beq-hmo 71000-Usa /Quadrox-i Adult recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-iR, used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Venous Hardshell Cardiotomy Reservoir recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Venous Hardshell Cardiotomy Reservoir recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Small Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Pediatric, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-iR, used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Beq-HMOD70000-Usa/Quadrox-iD recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-iD Pediatric, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-iD Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox -i Neonatal, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Beq-hmo 50000-Usa/ Quadrox-i Small recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Pediatric, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox-i Small Adult, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
7 Jun 2023Device	CLASS II	Quadrox -i Neonatal, Oxygenator used during cardiopulmonary bypass recalled	Maquet Medical Systems USA	Sterility	Nationwide
8 Mar 2023Device	CLASS II	Beq-hls 5050 Usa recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.