Balt Usa recalls

Balt Usa has 7 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 5 Nov 2025. 7 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is foreign material.

Total recalls7since 2022

Last 12 months1reported

Class I114% of total

Ongoing7latest 5 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 2 0Jul 0 0 0Oct 1 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 14%Class II 6 86%Class III 0 0%

Why balt usa is recalled

Product types

Heart & Vascular Devices457%
Other Medical Devices343%

By year

2025343%
2024114%
2022343%

Ongoing balt usa recalls

7 active

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS I	MEGA Ballast Distal Access Platform Mega Ballast recalled by Balt Usa	Balt Usa	Sterility	12 states
25 Jun 2025Device	CLASS II	Optima Coil System REFs recalled by Balt Usa	Balt Usa	Foreign Material	Nationwide
25 Jun 2025Device	CLASS II	Prestige Coil System REFs recalled by Balt Usa	Balt Usa	Foreign Material	Nationwide
14 Feb 2024Device	CLASS II	PRES0413CPKPL Prestige Coil Prestige Plus Complex Pack recalled	Balt Usa	Device Malfunction	28 states
26 Oct 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt Usa	Device Malfunction	Nationwide
14 Sep 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt Usa	Other	AZ, FL

All balt usa recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS I	MEGA Ballast Distal Access Platform Mega Ballast recalled by Balt Usa	Balt Usa	Sterility	12 states
25 Jun 2025Device	CLASS II	Optima Coil System REFs recalled by Balt Usa	Balt Usa	Foreign Material	Nationwide
25 Jun 2025Device	CLASS II	Prestige Coil System REFs recalled by Balt Usa	Balt Usa	Foreign Material	Nationwide
14 Feb 2024Device	CLASS II	PRES0413CPKPL Prestige Coil Prestige Plus Complex Pack recalled	Balt Usa	Device Malfunction	28 states
26 Oct 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt Usa	Device Malfunction	Nationwide
14 Sep 2022Device	CLASS II	Optima Coil System recalled by Balt Usa	Balt Usa	Other	AZ, FL
2 Mar 2022Device	CLASS II	The Optima Coil System consists of an implantable recalled by Balt Usa	Balt Usa	Labeling Errors	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.