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.

2751–2775 of 9607

  • ModerateFDA (Devices)·Z-1742-2019·2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1733-2019·2019-06-12

    Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications

    Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.

    Product
    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2019·2019-06-12

    I.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking

    I.T.S. GmbH is recalling 65 titanium rim plates because they have the wrong article number laser marked on them. The devices were distributed in the US and several international countries.

    Product
    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2019·2019-06-12

    Zimmer Biomet Recalls Lineum Translation Screws Due to Incorrect Length Marking

    Zimmer Biomet is recalling 64 Lineum 4.35mm x 28mm Translation Screws because the tulip head is incorrectly etched with '24MM' instead of '28MM'.

    Product
    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to resto
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1730-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life

    Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.

    Product
    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2019·2019-06-12

    Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size

    Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.

    Product
    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1731-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error

    Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.

    Product
    Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1721-2019·2019-06-12

    Kerr/Pentron Recalls Glutaraldehyde Solution Due to Labeling Discrepancy

    Kerr/Pentron is recalling Regimen 28 Day Glutaraldehyde Solution because the bottle label states a 45-minute immersion time, while the product instructions specify 90 minutes.

    Product
    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
    Category
    Medical Device
    Distribution
    21 states
  • CriticalUSDA FSIS·067-2019·2019-06-09

    Taylor Farms Recalls Bacon Quiche for Undeclared Egg Allergen

    Taylor Farms Illinois is recalling 51 pounds of Jarlsberg and bacon quiche because the label failed to list eggs, a known allergen.

    Product
    Taylor Farms Illinois, Inc — Taylor Farms Illinois, Inc. Recalls Bacon Quiche Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1439-2019·2019-06-05

    Wegman's Neptune Salad Recalled for Undeclared Milk Allergen

    Wegmans Food Markets is recalling Neptune Salad containers because old labels failed to declare the milk allergen.

    Product
    Wegman's Neptune Salad 1 lb containers, UPC Begins with 2010883100000, Model/catalog # 13081
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1423-2019·2019-06-05

    Paximadi Plain Biscotti Recalled for Undeclared Milk Allergen

    Paximadi Co. LLC is recalling Plain Biscotti because the label declares butter but fails to declare milk, a common allergen.

    Product
    Biscotti-Plain. Product is bulk packed in a master cardboard case and each master case contains either 48 or 36 individual biscotti. There are 12 Biscotti per layer and separated between layers with wax paper. Label applied to the exterior of master case only. The master ca
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1313-2019·2019-06-05

    Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.

    Product
    INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2019·2019-06-05

    K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.

    Product
    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and mai
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1491-2019·2019-06-05

    K2M Fenestrated Taps Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.

    Product
    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration tech
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1681-2019·2019-06-05

    King LTS-D Kit Size 1 Recalled for Incorrect Packaging and Labeling

    King Systems Corp. dba Ambu, Inc. is recalling 270 King LTS-D Kit Size 1 units because they were incorrectly packaged and labeled as size 1 products.

    Product
    King LTS-D Kit Size 1, Model Number KLTSD431
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1392-2019·2019-05-29

    Trader Joe's Fire Roasted Vegetables Recalled for Undeclared Milk Allergen

    Ardo N.V. is recalling Trader Joe's Fire Roasted Vegetables with Balsamic Butter Sauce because the label lists butter but fails to declare milk.

    Product
    Trader Joe s Fire Roasted Vegetables With Balsamic Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0077 5175
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1391-2019·2019-05-29

    Trader Joe's Vegetable Melange Recalled for Undeclared Milk Allergen

    Ardo N.V. is recalling Trader Joe's Vegetable Melange in Seasoned Butter Sauce because the label lists butter but fails to declare milk.

    Product
    Trader Joe s Vegetable Melange In Seasoned Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0033 7038
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1383-2019·2019-05-29

    Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors

    Beckman Coulter is recalling 2,059 UniCel DxH 600 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2019·2019-05-29

    Beckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling UniCel DxH 800 analyzers because sporadic platelet results may be erroneously elevated without system flags, potentially leaving thrombocytopenia unrecognized.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient popula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1307-2019·2019-05-29

    Septodont Recalls Articadent Dental Cartridges Due to Carton Mislabeling

    Septodont Inc. is recalling 240 cartons of Articadent dental cartridges because the printed cartons contained text for both Articadent and Xylocaine, though the cartridges themselves are correctly labeled.

    Product
    ARTICADENT — ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2019·2019-05-29

    Mallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up

    Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules because 8 mcg and 24 mcg bottles were found with incorrect contents.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    Distributed nationwide