Labeling Errors recalls

2,665 recalls have been issued for labeling errors, from 2012 to 21 Oct 2026. 99 of them came in the last 12 months. 418 were classified Class I.

Total recalls2,665since 2012

Last 12 months99reported

Class I41816% of total

Ongoing494latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

10Nov '24 8 15 6Feb 7 15 7May 12 13 13Aug 11 7 4Nov 15 1 23Feb 13 5 3May 1 6 13Aug 10 5

Severity split

Class I 418 16%Class II 1,841 69%Class III 400 15%Other/pending 6

Why labeling errors is recalled

Labeling Errors2,665100%

Companies

Product types

Brands

By year

2026803%
20251255%
20241576%
2023883%
20221134%
20211154%
202030311%
2019883%
20181405%
20171184%

Ongoing labeling errors recalls

494 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	The Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS II	REF: P65 ST862 CoLag Screw, FT, 6.7X62.5 mm recalled by In2bones USA	In2bones USA	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS II	The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled	Radiometer Medical ApS	Labeling Errors	Nationwide
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	Philips EPIQ Elite Diagnostic Ultrasound System recalled	Philips Ultrasound	Labeling Errors	Nationwide

All labeling errors recalls, newest first

2,665 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	The Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS II	REF: P65 ST862 CoLag Screw, FT, 6.7X62.5 mm recalled by In2bones USA	In2bones USA	Labeling Errors	Nationwide
21 Oct 2026Device	CLASS II	The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled	Radiometer Medical ApS	Labeling Errors	Nationwide
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	Philips EPIQ Elite Diagnostic Ultrasound System recalled	Philips Ultrasound	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
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
26 Aug 2026Food	CLASS III	Fudge Brownie Gourmet Popcorn recalled by Prospector PopcornProspector	Prospector Popcorn	Labeling Errors	45 states
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Drug	CLASS I	Kian Pee Wan Capsules recalled by Buy-Herbal	Buy-Herbal	Labeling Errors	NY
12 Aug 2026Device	CLASS II	Blom-Singer Classic Indwelling Voice Prosthesis recalled	Freudenberg Medical	Labeling Errors	Nationwide
12 Aug 2026Device	CLASS II	Blom-Singer Classic Indwelling Voice Prosthesis recalled	Freudenberg Medical	Labeling Errors	Nationwide
5 Aug 2026Device	CLASS II	L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled	Argon Medical Devices	Labeling Errors	28 states
5 Aug 2026Device	CLASS II	L-Cath Midline S/L Catheter (3F) recalled by Argon Medical Devices	Argon Medical Devices	Labeling Errors	28 states
29 Jul 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	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.