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.

8551–8575 of 9611

  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2013·2013-08-14

    Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error

    Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.

    Product
    Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling

    Smith & Nephew is recalling specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1921-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-856-2013·2013-08-14

    Zolpidem Tartrate Tablets Recalled for Potential Unit Dose Mispackaging

    American Health Packaging is recalling Zolpidem Tartrate 5 mg tablets due to a packaging error that may result in blisters containing more than one tablet.

    Product
    Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1872-2013·2013-08-14

    Precision Dynamics Recalls Non-Sterile Viscot Surgical Skin Markers

    Precision Dynamics Corporation is recalling 1,200 non-sterile Viscot surgical skin markers because they were mislabeled as sterile.

    Product
    Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurat
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1914-2013·2013-08-14

    Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the iden
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1873-2013·2013-08-14

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1887-2013·2013-08-14

    Cordis OPTEASE Retrieval IVC Filter Recall for Labeling Clarification

    Cordis Corporation is recalling 33,000 units of the OPTEASE Retrieval IVC Filter to provide additional labeling that minimizes the likelihood of implanting the filter backwards.

    Product
    Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2013·2013-08-07

    SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments

    SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.

    Product
    Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1755-2013·2013-08-07

    Fisher's New England Clam Chowder Recalled for Undeclared Allergens

    Fisher's Homestyle Salads LLC is recalling New England Clam Chowder because the packaging fails to list milk, corn, and specific shellfish allergens.

    Product
    Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1746-2013·2013-08-07

    Whole Foods Pimento Cheese Recalled for Undeclared Egg Allergen

    Whole Foods Market is recalling pimento cheese because the label failed to declare mayonnaise, which contains egg.

    Product
    Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1864-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1762-2013·2013-08-07

    El Campestre Ceviche De Basa Recalled for Mislabeling Fish Species

    El Campestre is recalling Ceviche De Basa because the product contains Swai fish instead of the labeled Basa fish.

    Product
    El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1826-2013·2013-08-07

    SteriTec Biological Indicator Test Packs Recalled for Labeling Discrepancy

    SteriTec is recalling specific lots of biological indicator test packs because the readout time does not match label claims.

    Product
    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1866-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1825-2013·2013-08-07

    SteriTec Biological Indicator Test Packs Recalled for Readout Time Issues

    SteriTec is recalling specific lots of Getinge Assure Accufast BI Test Packs because the readout time does not match label claims.

    Product
    Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2013·2013-08-07

    Stryker Recalls Left GAMMA3 Nails Marked as Right

    Stryker Howmedica Osteonics is recalling five units of the GAMMA3 System Long Nail Kit, Left, because they are incorrectly marked as right nails.

    Product
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1823-2013·2013-08-07

    SteriTec EZTest Steam Biological Indicator Recalled for Labeling Inaccuracy

    SteriTec is recalling 200 units of EZTest Steam Biological Indicators because the readout time does not match the label claims.

    Product
    Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1765-2013·2013-08-07

    El Campestre Recalls Shrimp Product for Missing English Labeling

    El Campestre is recalling 37 cartons of Camaron Aquachile because shrimp are not listed in English on the label, although the whole shrimp are visible.

    Product
    El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1862-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1764-2013·2013-08-07

    El Campestre Ceviche De Camaron Recalled for Shrimp Mislabeling

    El Campestre is recalling Ceviche De Camaron because shrimp is not listed in English on the label, despite the whole shrimp being visible.

    Product
    El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1865-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide