Reflexion Medical recalls

Reflexion Medical has 4 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 8 Apr 2026. 3 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls4since 2022

Last 12 months1reported

Class I00% of total

Ongoing3latest 8 Apr 2026

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 1 0Oct 0 0 0Jan '26 0 0 1Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why reflexion medical is recalled

Product types

By year

2026125%
2025125%
2024125%
2022125%

Ongoing reflexion medical recalls

3 active

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	RefleXion X1 Radiotherapy System recalled by Reflexion Medical	Reflexion Medical	Device Malfunction	8 states
10 Sep 2025Device	CLASS II	RefleXion X1 recalled by Reflexion Medical	Reflexion Medical	Lead & Heavy Metals	Nationwide
5 Jun 2024Device	CLASS II	RefleXion X1 Radiotherapy System recalled by Reflexion Medical	Reflexion Medical	Device Malfunction	6 states

All reflexion medical recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	RefleXion X1 Radiotherapy System recalled by Reflexion Medical	Reflexion Medical	Device Malfunction	8 states
10 Sep 2025Device	CLASS II	RefleXion X1 recalled by Reflexion Medical	Reflexion Medical	Lead & Heavy Metals	Nationwide
5 Jun 2024Device	CLASS II	RefleXion X1 Radiotherapy System recalled by Reflexion Medical	Reflexion Medical	Device Malfunction	6 states
19 Jan 2022Device	CLASS II	Radiotherapy System - System Label: "*** refleXion recalled	Reflexion Medical	Other	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.