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.

8576–8600 of 9611

  • ModerateFDA (Devices)·Z-1822-2013·2013-08-07

    SteriTec Steam Biological Indicators Recalled for Labeling Inaccuracy

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

    Product
    Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1827-2013·2013-08-07

    SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues

    SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.

    Product
    Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and
    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-1829-2013·2013-08-07

    SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy

    SteriTec is recalling 360 units of Steam Biological Test Packs because the readout time does not match the label claims.

    Product
    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1849-2013·2013-08-07

    GE Healthcare Recalls LOGIQ e Ultrasound Systems for Patient Data Linking Error

    GE Healthcare is recalling 588 LOGIQ e ultrasound systems because image data from one patient may be linked to another patient's ID.

    Product
    GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types in
    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-1861-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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 (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-1806-2013·2013-07-31

    Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching

    Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.

    Product
    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1584-2013·2013-07-31

    Green Mountain Coffee Recalls Donut House K-Cup Packs Due to Mislabeling

    Green Mountain Coffee Roasters is recalling Donut House K-Cup packs because regular caffeinated coffee was packaged in boxes labeled as decaffeinated.

    Product
    Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1781-2013·2013-07-31

    Myoscience iovera Smart Tip Recalled for Missing US Labeling Requirements

    Myoscience Inc is recalling three iovera Smart Tip units because their labels lacked required US regulatory text and symbols.

    Product
    Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1808-2013·2013-07-31

    Stryker Neuroform 3 Stent System Recalled for Labeling Mismatch

    Stryker Neurovascular is recalling 23 units of the Neuroform 3 Microdelivery Stent System because the model numbers on the outer carton and inner pouch labels do not match.

    Product
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Micro
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1778-2013·2013-07-31

    National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual

    National Biological Corp is recalling Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-083 device.

    Product
    Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1810-2013·2013-07-31

    Medtronic Preimplantation Test Kit Recalled for Incorrect Expiration Dates

    Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.

    Product
    Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1779-2013·2013-07-31

    National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual

    National Biological Corp is recalling six Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-080 device.

    Product
    Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-805-2013·2013-07-24

    Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error

    Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.

    Product
    Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1727-2013·2013-07-24

    Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims

    Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.

    Product
    B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2013·2013-07-24

    Paa Laboratories Recalls Fetal Bovine Serum Due to Mislabeling

    Paa Laboratories is recalling approximately 280,000 liters of Fetal Bovine Serum because some products labeled as pure may contain added adult Bovine Serum Albumin.

    Product
    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1715-2013·2013-07-24

    Somersault Pacific Sea Salt Snacks Recalled for Flavor Mislabeling

    Somersault Snack Co. is recalling Pacific Sea Salt flavored nuggets because they were mispackaged with Santa Fe Salsa flavor. Consumers should check their packages for specific UPCs and sell-by dates.

    Product
    Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965
    Category
    Food
    Distribution
    17 states
  • LowFDA (Devices)·Z-1748-2013·2013-07-24

    Boston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error

    Boston Scientific is recalling 35 units of Alair Bronchial Thermoplasty Catheters because the expiration date on the inner tray is incorrect.

    Product
    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the A
    Category
    Medical Device
    Distribution
    Distributed nationwide