Labeling Errors recalls

2,659 recalls have been issued for labeling errors, from 2012 to 30 Sep 2026. 99 of them came in the last 12 months. 418 were classified Class I.

Total recalls2,659since 2012
Last 12 months99reported
Class I41816% of total
Ongoing488latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 418 16%Class II 1,836 69%Class III 400 15%Other/pending 5

Why labeling errors is recalled

By year

Ongoing labeling errors recalls

488 active

All labeling errors recalls, newest first

2,659 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIPhilips EPIQ Elite Diagnostic Ultrasound System recalledPhilips UltrasoundLabeling ErrorsNationwide
DeviceCLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIIQvitals Zone, automatically recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIFujifilm Synapse Pacs recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasLabeling ErrorsNationwide
DeviceCLASS IIIQecg Digital ECG recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIDigital ECG HD+12, HD+15 recalled by MidmarkMidmarkLabeling ErrorsNationwide
DeviceCLASS IIMerge PACS and Merge OrthoPACS recalled by Merge HealthcareMerge HealthcareLabeling ErrorsNationwide
DeviceCLASS IIPowerseal (in diameter) (long), Curved Jaw Sealer & Divider recalledOlympus Corporation of the AmericasLabeling ErrorsNationwide
DeviceCLASS IICardiac Workstation recalled by Philips North AmericaPhilips North AmericaLabeling ErrorsNationwide
DeviceCLASS IICardiac Workstation recalled by Philips North AmericaPhilips North AmericaLabeling ErrorsNationwide
FoodCLASS IIIBelgian Chocolate Toffee Gourmet Popcorn recalled by Prospector PopcornProspectorProspector PopcornLabeling Errors45 states
FoodCLASS IIChocolate Mocha Gourmet Popcorn recalled by Prospector PopcornProspectorProspector PopcornLabeling Errors45 states
FoodCLASS IIIMaple Walnut Ice Cream Gourmet Popcorn recalled by Prospector PopcornProspectorProspector PopcornLabeling Errors45 states
FoodCLASS IIIFudge Brownie Gourmet Popcorn recalled by Prospector PopcornProspectorProspector PopcornLabeling Errors45 states
DeviceCLASS IIGore Viabil Short Wire Biliary Endoprosthesis recalledW L Gore & AssociatesLabeling ErrorsNationwide
DeviceCLASS IIGore Viabil Short Wire Biliary Endoprosthesis recalledW L Gore & AssociatesLabeling ErrorsNationwide
DrugCLASS IKian Pee Wan Capsules recalled by Buy-HerbalBuy-HerbalLabeling ErrorsNY
DeviceCLASS IIBlom-Singer Classic Indwelling Voice Prosthesis recalledFreudenberg MedicalLabeling ErrorsNationwide
DeviceCLASS IIBlom-Singer Classic Indwelling Voice Prosthesis recalledFreudenberg MedicalLabeling ErrorsNationwide
DeviceCLASS IIL-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalledArgon Medical DevicesLabeling Errors28 states
DeviceCLASS IIL-Cath Midline S/L Catheter (3F) recalled by Argon Medical DevicesArgon Medical DevicesLabeling Errors28 states
DeviceCLASS IIPipeline Flex Embolization Device with Shield Technology recalledMicro TherapeuticsLabeling ErrorsNationwide
DeviceCLASS IIPipeline Flex Embolization Device with Shield Technology recalledMicro TherapeuticsLabeling ErrorsNationwide
DeviceCLASS IIOrthofix Minirail, Short, Lengthener recalled by Orthofix U.SOrthofix U.SLabeling Errors22 states
DeviceCLASS IIOrthofix Minirail, Articulated, Fixator, Vertical Axis recalledOrthofix U.SLabeling Errors22 states
DeviceCLASS IIOrthofix Articulated Minirail Fixator Horizontal Axis recalledOrthofix U.SLabeling Errors22 states
DeviceCLASS IIOrthofix Minirail, Standard Lengthener recalled by Orthofix U.SOrthofix U.SLabeling Errors22 states
DeviceCLASS IAutomated Impella Controller (AIC) recalled by AbiomedAbiomedLabeling ErrorsNationwide

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.