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.

1501–1525 of 9607

  • ModerateFDA (Devices)·Z-1432-2021·2021-04-28

    Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors

    Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.

    Product
    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0434-2021·2021-04-28

    Tropicana Recalls KeVita Cucumber Rosemary Kombucha Due to Mislabeling

    Tropicana Products, Inc. is recalling 5,479 cases of KeVita Cucumber Rosemary kombucha due to mislabeling of the bottled product inside the case.

    Product
    KeVita Cucumber Rosemary (primary package), 15.2 oz., glass bottles, 6 packages per case, refrigerated storage
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1433-2021·2021-04-28

    Boston Scientific AMS 700 Penile Prosthesis Reservoirs Recalled for Mislabeling

    Boston Scientific is recalling 23 AMS 700 penile prosthesis reservoirs because they were incorrectly labeled as a different model type.

    Product
    The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare is recalling 674 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 7 ADVIA 2120 automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2021·2021-04-21

    VGlove Nitrile Examination Gloves Recalled for Containing Latex

    HUBO International is recalling VGlove Nitrile examination gloves because they contain latex instead of nitrile, posing a risk to latex-allergic individuals.

    Product
    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1390-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling 32 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling ADVIA 2120 Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V275000·2021-04-21

    Airstream Recalls 2020-2021 Interstates Due to Incorrect Weight Rating Label

    Airstream is recalling 2020-2021 Interstate vehicles because the Gross Vehicle Weight Rating label may list incorrect occupant cargo capacity, potentially leading to vehicle overload.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1429-2021·2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2021·2021-04-21

    Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

    Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

    Product
    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1409-2021·2021-04-21

    OriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling

    OriGen Biomedical is recalling Evolve Cell Culture Bags because they were incorrectly labeled as free of phthalates.

    Product
    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-0429-2021·2021-04-21

    J-Basket Seaweed Snack Recalled for Undeclared Food Dyes

    JFC International is recalling J-Basket Premium Korean Seaweed Snack because Wasabi flavor packages were incorrectly labeled as Original, failing to declare FD&C Yellow 5 and FD&C Blue No 1.

    Product
    J-Basket Premium Korean Seaweed Snack - Wasabi flavor on outer wrap for 3 inner packages Inner packages labeled J-Basket Premium Seaweed Snack - Original. Net Wt 0.52 oz. (15g) 3-0.17 oz. (5g) packs Distributed by JFC International Inc., Los Angeles, CA 90040 Wasabi outer packa
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1430-2021·2021-04-21

    Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors

    Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.

    Product
    MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2021·2021-04-21

    Centinel Spine Recalls Prodisc C Devices Missing Orientation Marking

    Centinel Spine is recalling 49 Prodisc C cervical disc prostheses because the 'UP' orientation marking is missing from the superior plate.

    Product
    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0330-2021·2021-04-21

    Enovachem Recalls Methylprednisolone Tablets Due to Illegible Labeling

    Enovachem Pharmaceuticals is recalling Methylprednisolone Tablets due to misaligned printing on the blister card that renders dosing instructions illegible.

    Product
    Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, Do
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0326-2021·2021-04-14

    Alembic Pharmaceuticals Recalls Telmisartan Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling 12,288 bottles of Telmisartan 20 mg tablets due to a label mixup. The product was distributed nationwide in the United States.

    Product
    TELMISARTAN — TELMISARTAN (TELMISARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2021·2021-04-14

    Quaker Rice Crisps Recalled for Undeclared Soy Allergen

    The Quaker Oats Company is recalling Quaker Rice Crisps Sweet Barbecue Flavor due to undeclared soy. The recall covers 4,550 bags distributed to 21 states.

    Product
    Quaker Rice Crisps Sweet Barbecue Flavor, 3.03 oz. bag, UPC 0 30000 31984 0
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1348-2021·2021-04-14

    Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display

    Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.

    Product
    Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
    Category
    Medical Device
    Distribution
    Distributed nationwide