The Recall Desk

Hazard

Mis Labeling recalls

9,611 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,611
Critical
161
Severe
589
Most recent
2026-09-24

Of the 9,611 mis labeling recalls we have scored against our rubric, 161 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 589 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

8351–8375 of 9611

  • HighFDA (Devices)·Z-0104-2014·2013-11-06

    Siemens Blood Gas Analyzers Recalled for Patient Identification Error Risk

    Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0087-2014·2013-11-06

    Pringles Salt and Vinegar Chips Recalled for Undeclared Milk Allergen

    Kellogg Canada is recalling Pringles Salt and Vinegar Potato Chips because the packaging failed to declare milk as an ingredient, violating Canadian labeling regulations.

    Product
    Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0117-2014·2013-11-06

    Integra Camino Intracranial Pressure Monitoring Catheters Recalled for Missing MR Safety Labeling

    Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.

    Product
    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0081-2014·2013-11-06

    Cordis Recalls Optease Vena Cava Filter Due to Printing Error

    Cordis is recalling 29,395 Optease Vena Cava Filters because a printing error on one unit caused it to be implanted upside down, requiring an additional procedure.

    Product
    Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2014·2013-11-06

    Atossa ForeCYTE Breast Health Test Recalled for Labeling and Marketing Concerns

    Atossa Genetics is recalling ForeCYTE Breast Health Test kits due to FDA concerns regarding instructions for use and promotional claims.

    Product
    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Flui
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2014·2013-11-06

    Sysmex pocH-100i Automated Hematology Analyzer Recalled for Data Omission

    Sysmex America Inc is recalling 193 pocH-100i Automated Hematology Analyzers because the thermal printer may omit digits or decimal points in printed results.

    Product
    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2014·2013-10-30

    Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error

    Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.

    Product
    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2014·2013-10-30

    Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling

    Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.

    Product
    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2014·2013-10-30

    GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software

    GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.

    Product
    Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other inform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2014·2013-10-30

    OPTI LION E-Plus Cassettes Recalled for Incorrect Barcode Labeling

    OPTI Medical Systems is recalling OPTI LION E-Plus Cassettes because incorrect barcodes may affect performance over time and cause quality control failures.

    Product
    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2014·2013-10-30

    Aesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions

    Aesculap, Inc. is recalling 217 UNITRAC Pneumatic Retraction Arms because updated instructions for use are required to ensure safe operation and extend product life.

    Product
    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue

    Advanced Sterilization Products is recalling STERRAD 100NX Cassettes because the leak indicator is effective for only 12 months, not the labeled 15 months.

    Product
    STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66207-001·2013-10-30

    Hi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines

    Hi-Tech Pharmacal is recalling specific lots of Giltuss and Exactuss cough and cold medicines because they contain less phenylephrine than labeled.

    Product
    GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 0071
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0004-2014·2013-10-23

    Dutch Valley Honey Roasted Peanuts Recalled for Undeclared Allergens

    Dutch Valley Food Development Inc. is recalling Honey Roasted Peanuts due to undeclared milk and wheat allergens.

    Product
    Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. Allergen info: peanut and soy ingredients. Also states that facility also pr
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2014·2013-10-23

    Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk

    Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.

    Product
    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2014·2013-10-23

    Abbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates

    Abbott Laboratories is recalling specific lots of Clinical Chemistry Phosphorus Reagent because the supplier assigned incorrect expiration dates to the product.

    Product
    Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-66373-001·2013-10-16

    Sandoz Recalls Hydroxychloroquine Tablets Due to Illegible Logo

    Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets because the logo on some tablets is illegible.

    Product
    Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2013·2013-10-09

    King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling

    King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.

    Product
    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2014·2013-10-09

    Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling

    Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.

    Product
    Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2014·2013-10-09

    ASO Recalls SHOPKO Waterproof Adhesive Pads Labeled as Antibacterial

    ASO, LLC is recalling SHOPKO Waterproof Adhesive Pads because they were labeled as antibacterial but did not contain antibacterial ingredients.

    Product
    SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2302-2013·2013-10-09

    Medtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling

    Medtronic is recalling 122 units of NC Sprinter Balloon Dilatation Catheters because the compliance chart lists the size as 2.5mm instead of the correct 2.25mm.

    Product
    NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplas
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0003-2014·2013-10-09

    Cordis ADROIT 6F Guiding Catheter Recalled for Labeling Error

    Cordis Corporation is recalling 1,238 units of ADROIT 6F Guiding Catheters due to a labeling error regarding the conversion of the inner diameter from inches to millimeters.

    Product
    Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2014·2013-10-09

    King Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error

    King Systems Corp. is voluntarily recalling one case of King LTS-D Oropharyngeal Airways because the package label incorrectly identified the size.

    Product
    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspirati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1966-2013·2013-10-09

    Green Mountain Coffee Recalls Tully's Decaf K-Cup Packs Due to Caffeine Contamination

    Green Mountain Coffee Roasters is recalling Tully's House Blend Decaffeinated K-Cup Packs because regular caffeinated packs were mistakenly included in decaffeinated retail boxes.

    Product
    Tully's House Blend Decaffeinated K-Cup¿ Packs (12-ct retail box) Product Code: 8803; UPC: 099555088038
    Category
    Food
    Distribution
    5 states