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Berlin Heart recalls

Berlin Heart has 2 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 17 Jun 2026. 1 is still ongoing. 1 was reported in the last 12 months.

Total recalls2since 2023

Last 12 months1reported

Class I150% of total

Ongoing1latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 1 0 0Aug 0 0

Severity split

Class I 1 50%Class II 1 50%Class III 0 0%

Why berlin heart is recalled

Other Reasons150%
Packaging Defects150%

Product types

Other Medical Devices2100%

By year

2026150%
2023150%

Ongoing berlin heart recalls

1 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Excor Pediatric Ventricular Assist Device recalled by Berlin Heart	Berlin Heart	Packaging Defects	Nationwide

All berlin heart recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Excor Pediatric Ventricular Assist Device recalled by Berlin Heart	Berlin Heart	Packaging Defects	Nationwide
31 May 2023Device	CLASS I	Excor Pediatric Ventricular Assist Device Blood Pumps recalled	Berlin Heart	Other	16 states

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.