The Recall Desk

Hazard

Labeling Defect recalls

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

What the numbers show

Total
26
Critical
0
Severe
3
Most recent
2025-07-09

Of the 26 labeling defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (12%) 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 labeling defect 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.

1–25 of 26

  • SevereFDA (Devices)·Z-2036-2025·2025-07-09

    BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips

    Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.

    Product
    BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2025·2025-06-11

    Artisan Multigrain Bread recalled for undeclared egg allergen

    NEW GRAINS GLUTEN FREE BAKERY is recalling Artisan Multigrain Bread (32 oz packages) distributed in Utah because label printing quality failed to clearly declare the egg allergen present in the product.

    Product
    Artisan Multigrain Bread: Gluten-free multigrain bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Egg whites, Tapioca flour, Honey, Golden flax seed, Palm oil, Potato flour, Yeast, Sugar, Psyllium husk powder, Rice bran, Sea salt,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1058-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0208-2025·2025-01-29

    Venlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification

    Appco Pharma LLC is recalling Venlafaxine Extended-Release Tablets, 150mg, due to missing tablet identification imprints. The defect affects 1,380 bottles distributed nationwide.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2025·2024-12-04

    Medline Endo Kit Recall: Missing Lot and Expiration Date Labels

    Medline is recalling Endo Kit models containing Olympus components with missing sterile and manufacturing lot numbers and expiration dates on packaging. Without this labeling, medical facilities cannot verify product expiration or track inventory.

    Product
    ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3225-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3143-2024·2024-09-25

    Seer Home EEG System Recalled for EMC Non-Compliance

    Seer Home System ambulatory EEG devices were recalled due to electromagnetic compatibility non-compliance and manufacturing control deficiencies. The issue may affect signal recording reliability in home EEG monitoring.

    Product
    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3070-2024·2024-09-18

    Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled

    Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.

    Product
    KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1469-2024·2024-07-17

    Gluten Free Cookies Recalled for Missing Ingredient Statement on Label

    C. Krueger Finest Baked Goods is recalling 3,347 Gluten Free White Chocolate Cherry Oatmeal Cookies due to missing ingredient statements on labels, preventing consumers from identifying allergens and dietary content.

    Product
    C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2035-2024·2024-06-19

    NEOMED Pharmacy Syringes recalled due to missing expiration dates

    Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2024·2024-02-14

    FDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects

    The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.

    Product
    Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2024·2024-02-14

    Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging

    Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.

    Product
    Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0810-2024·2024-01-31

    Medical Device MRI Cooling Cabinet Warning Label Missing High-Voltage Symbol

    Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.

    Product
    Ingenia Ambition X, Model No. 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2023·2023-03-15

    Sprint 200 Wheeled Stretcher Siderail Labeling Update to Prevent Falls

    FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.

    Product
    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-0181-2023·2023-02-01

    Advil Ibuprofen Tablets Recalled for Illegible Labels

    Glaxosmithkline Consumer Healthcare is recalling Advil ibuprofen 200 mg tablets because adhesive migrated onto labels, causing them to tear when peeled. This affects 321,246 tablets distributed nationwide.

    Product
    Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2023·2022-12-28

    Tobra Bone Cement Recall for Missing Turkish Instructions

    Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.

    Product
    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0202-2023·2022-11-23

    Urological Irrigation Kit Recalled for Illegible Barcode Labels

    Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.

    Product
    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1852-2022·2022-10-05

    YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall

    Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.

    Product
    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateNHTSA·22V392000·2022-06-02

    2022 Cadillac XT6 brake fluid reservoir cap warning label missing

    General Motors is recalling certain 2022 Cadillac XT6 vehicles because the brake fluid reservoir cap may be missing its required warning label. Without the label, brake fluid could become contaminated with debris, affecting brake performance.

    Product
    CADILLAC — CADILLAC XT6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0833-2022·2022-04-06

    CareFusion Endoscopic Equipment Recalled for Missing Instructions for Use

    CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.

    Product
    (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2022·2021-12-15

    AmericanScreening Hand Sanitizer Recalled for Misleading Bottle Resemblance

    AmericanScreening Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ bottles, is being recalled nationwide because the containers resemble drinking water bottles, posing a risk of accidental ingestion.

    Product
    AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2022·2021-12-01

    Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels

    Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.

    Product
    CombiDiagnost R90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V384000·2020-07-01

    Volvo VNL and VNR Buses: Incorrect Axle Weight Rating Labels

    Volvo is recalling certain 2018–2021 VNL and VNR buses with incorrect Gross Axle Weight Rating labels on rear drive axles. Overloading could cause wheel hub failure and increase the risk of a crash.

    Product
    VOLVO — VOLVO VNR, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide