The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (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.

2651–2675 of 9607

  • ModerateFDA (Devices)·Z-2069-2019·2019-07-31

    Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling

    Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.

    Product
    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1987-2019·2019-07-31

    Abbott C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update

    Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2019·2019-07-31

    Abbott Immunoglobulin A Diagnostic Assay Recalled for Instruction Manual Errors

    Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.

    Product
    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2019·2019-07-31

    Becton Dickinson Recalls 3mL Safety-Lok Syringes Due to Incorrect Scale Markings

    Becton Dickinson is recalling 428,800 3mL Safety-Lok Syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.

    Product
    3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1991-2019·2019-07-31

    Abbott Apolipoprotein A1 Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 2,112 Apolipoprotein A1 assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an incr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1942-2019·2019-07-31

    Dietary Supplement Recalled for Incorrect Labeling and Insufficient Ingredient

    Nexagen, LLC is recalling Acid Rain Ass Kicking Fat Destroyer dietary supplements because the product contains insufficient Higenamine and incorrectly lists Cayenne Pepper and Choline Bitartrate on the label.

    Product
    ACID RAIN ASS KICKING FAT DESTROYER APOCALYPSE LABZ; 45 CAPSULES; 1 DIETARY SUPPLEMENT; UPC 6 11138 28792 0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2007-2019·2019-07-31

    Becton Dickinson Recalls 3mL Luer-Lok Syringes With Incorrect Scale Markings

    Becton Dickinson is recalling 3mL Luer-Lok syringes because the scale markings were printed incorrectly, resulting in missing or partially printed numbers and lines.

    Product
    3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1566-2019·2019-07-31

    La Fresh Sunnyside Lotion Wipes Recalled for Lack of Approval

    La Fresh Group is recalling 83,050 packets of Sunnyside Lotion Wipes because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octi
    Category
    Drug
    Distribution
    0 states
  • SevereUSDA FSIS·078-2019·2019-07-25

    Home Market Foods Recalls Frozen Meatballs for Undeclared Allergens

    Home Market Foods is recalling approximately 53,217 pounds of frozen ready-to-eat beef and pork meatballs because they contain undeclared milk and wheat allergens.

    Product
    Home Market Foods, Inc. — Home Market Foods, Inc. Recalls Frozen Ready-To-Eat Beef and Pork Meatball Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1939-2019·2019-07-24

    Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump Recalled for Labeling Defects

    Datascope Corp. is recalling 6,197 Cardiosave Hybrid Intra-Aortic Balloon Pumps worldwide due to inadequate labeling regarding battery maintenance.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1608-2019·2019-07-24

    Kroger Stuffed Mushrooms Recalled for Undeclared Soy Allergen

    GH Foods is recalling Kroger Stuffed Mushrooms because the product contains soy, which is not declared on the label.

    Product
    Kroger Stuffed Mushrooms; Net Wt. 7 oz. (193 g) over-wrapped tray Perishable, Keep Refrigerated. Cook before consumption UPC: 2676614086 Distributed by Renaissance Food Group, LLC. 1730 Eastbridge Ave. Riverside, CA 92507
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V545000·2019-07-24

    Mercedes-Benz Metris Recalled for Incorrect Operator's Manual

    Daimler Vans USA is recalling 2019 Mercedes-Benz Metris vehicles because the printed operator's manual may not match the vehicle's features, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2019·2019-07-24

    Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

    Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

    Product
    Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stab
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1975-2019·2019-07-24

    Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.

    Product
    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1974-2019·2019-07-24

    Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.

    Product
    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1490-2019·2019-07-24

    Lupin Recalls Gatifloxacin Ophthalmic Solution Due to Missing Labels

    Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1546-2019·2019-07-17

    Baumer Foods Recalls Mislabeled Worcestershire Sauce Sold as Soy Sauce

    Baumer Foods is recalling 10 FL OZ bottles of Worcestershire sauce mislabeled as soy sauce due to an undeclared allergen. The product was distributed to retail locations in six northeastern states.

    Product
    Soy Sauce, 10 FL OZ
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1549-2019·2019-07-17

    Ziba Nut Edamame Green Beans Recalled for Undeclared Soy Allergen

    Ziba Nut Incorporated is recalling salted and roasted edamame green beans because the product does not declare soy on the label.

    Product
    OU Kosher Salted and Roasted Edamame Green Beans (Regular Salt), Packing: 2x11 lbs, Net WT: 22lbs, Product Of China
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1955-2019·2019-07-17

    MAHURKAR and Argyle acute hemodialysis catheters recalled for inaccurate priming volume labels

    COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.

    Product
    MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 881714900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2019·2019-07-17

    Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging

    Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.

    Product
    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • HighUSDA FSIS·074-2019·2019-07-14

    Fieldsource Recalls Marinated Beef and Chicken Due to Undeclared Wheat

    Fieldsource Food Systems is recalling marinated beef and chicken cubes because they contain undeclared wheat, a known allergen.

    Product
    Fieldsource Food Systems, Inc. — Fieldsource Food Systems, Inc. Recalls Beef and Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1525-2019·2019-07-10

    Will's Fresh Foods Macaroni Salad Recalled for Undeclared Wheat Allergen

    Woolery Enterprises Inc. is recalling Will's Fresh Foods Macaroni Salad because wheat is not declared as an ingredient or allergen.

    Product
    Will's Fresh Foods Macaroni Salad, All Natural; A true Classic salad made astonishingly delicious - semolina pasta, real mayonnaise and crunchy vegetables; NET WT. 12 oz.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1926-2019·2019-07-10

    Infinium Medical Recalls CLEO and Tranquility VS Patient Monitors

    Infinium Medical is recalling 95 CLEO and Tranquility VS patient monitors because their FDA clearance did not include the temperature monitor accessory option.

    Product
    CLEO Patient Monitor /Tranquility VS Patient Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide