Labeling Errors recalls

2,692 recalls have been issued for labeling errors, from 2012 to 2 Sep 2026. 104 of them came in the last 12 months. 418 were classified Class I.

Total recalls2,692since 2012

Last 12 months104reported

Class I41816% of total

Ongoing486latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

48Oct '24 10 8 15Jan '25 6 7 15Apr 7 12 13Jul 13 11 7Oct 4 14 1Jan '26 23 12 5Apr 3 2 6Jul 13 5

Severity split

Class I 418 16%Class II 1,866 69%Class III 403 15%Other/pending 5

Why labeling errors is recalled

Labeling Errors2,692100%

Companies

Product types

Brands

By year

2026703%
20251245%
20241596%
2023883%
20221144%
20211154%
202030111%
2019893%
20181415%
20171315%

Ongoing labeling errors recalls

486 active

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas	FUJIFILM Healthcare Americas	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Digital ECG HD+12, HD+15 recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

All labeling errors recalls, newest first

2,692 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas	FUJIFILM Healthcare Americas	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Digital ECG HD+12, HD+15 recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide
26 Aug 2026Food	CLASS III	Belgian Chocolate Toffee Gourmet Popcorn recalled by Prospector PopcornProspector	Prospector Popcorn	Labeling Errors	45 states
26 Aug 2026Food	CLASS II	Chocolate Mocha Gourmet Popcorn recalled by Prospector PopcornProspector	Prospector Popcorn	Labeling Errors	45 states
26 Aug 2026Food	CLASS III	Maple Walnut Ice Cream Gourmet Popcorn recalled by Prospector PopcornProspector	Prospector Popcorn	Labeling Errors	45 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.