The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

29401–29425 of 50499

  • HighFDA (Devices)·Z-1279-2018·2018-04-11

    Life Technologies Recalls Oncomine Dx Target Test User Guides

    Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.

    Product
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1289-2018·2018-04-11

    Invivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display

    Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.

    Product
    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1309-2018·2018-04-11

    C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2018·2018-04-11

    Dynavox T15 Speech Generating Device Recalled Due to Battery Defect

    Dynavox Systems LLC is recalling 307 T15 Speech Generating Devices because the integral battery may out-gas and swell after long periods of disuse, potentially causing the device case to separate.

    Product
    Dynavox T15 Speech Generating Device ( including Batteries)
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·18735·2018-04-10

    2017 Can-Am Outlander ATVs Recalled for Steering Shaft Crash Hazard

    BRP is recalling 2017 Can-Am Outlander and Outlander Max ATVs because the dynamic power steering shaft can break, causing a loss of steering control and crash hazard.

    Product
    2017 Can-Am Outlander and Outlander Max All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V228000·2018-04-10

    Indian Motorcycle Recalls 2018 Models Due to Unintended Starting Risk

    Indian Motorcycle is recalling 3,341 2018 models because corrosion in the combination switch may cause the bike to start unintentionally, posing a carbon monoxide risk.

    Product
    INDIAN — INDIAN SPRINGFIELD DARK HORSE, CHIEF, CHIEF VINTAGE, CHIEFTAIN ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V225000·2018-04-09

    MCI Recalls 2018 J4500 Motor Coaches Due to Window Separation Risk

    Motor Coach Industries is recalling 2018 MCI J4500 motor coaches because the rear left window may separate, creating a road hazard and increasing crash risk.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V223000·2018-04-09

    MCI Recalls 2018 J4500 Coaches Due to Taillight Wiring Defect

    Motor Coach Industries is recalling 2018 J4500 vehicles because a wiring harness may contact the coolant tank, causing the left taillight to fail and reducing visibility.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V222000·2018-04-06

    Forest River Surveyor Recalled for Incorrect Federal Tire Placard Information

    Forest River is recalling 2018 Surveyor recreational trailers because the Federal Placard lists incorrect tire sizes and pressures, which could lead to over-inflation and increased crash risk.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2018·2018-04-04

    Inova Diagnostics Recalls QUANTA-Lyser 240 IFA Due to Power Supply Defect

    Inova Diagnostics is recalling one QUANTA-Lyser 240 IFA instrument because its power supply was not manufactured to specification, potentially causing loss of protective grounding.

    Product
    QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1197-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because they failed a clinical analysis showing surgical revision rates exceeded acceptance criteria.

    Product
    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0974-2018·2018-04-04

    J.M. Rosen's Cheesecake Recalled Due to Foreign Object Contamination

    J.M. Rosen's is recalling Fantasy cheesecake slices because a retail employee found a small rubber object in the product.

    Product
    J.M. Rosen's Cheesecake - Fantasy; 9 - Unit- 64 Slices in a case box; Product #55993 UPC 6 89076 70759 6; INGREDIENTS: Cream Cheese (Pasteurized Milk. and Cream, Cheese Culture, Salt, ( Stabilizers (Xanthan Gum, and/or Carob Bean Gum, and/or Guar Gum), Unbleached flour…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1252-2018·2018-04-04

    Stryker Recalls Orthopedic Cement Mixers Due to Sterility Assurance Issues

    Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0975-2018·2018-04-04

    IDLife Protein Bars Recalled for Undeclared Almond Allergen

    IDLife, LLC is recalling IDLife Protein Bar Chocolate and Peanut Butter because the product contains almonds but does not declare them on the label.

    Product
    IDLife Protein Bar Chocolate and Peanut Butter (SKU 16-0012) Organic, non-GMO and gluten-free protein bar. Individually wrapped bars, packaged 10 to a box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1177-2018·2018-04-04

    ConMed Pediatric Defibrillation Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 pediatric defibrillation electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2018·2018-04-04

    Cook Inc. Recalls Marrs Laparoscopic GIFT Catheters Due to Quality Testing Gaps

    Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.

    Product
    Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0977-2018·2018-04-04

    IDLife Kids Bar Recalled for Undeclared Almond and Coconut Allergens

    IDLife, LLC is recalling IDLife Kids Bar Chocolate and Mixed Berry because allergen testing detected almonds and coconut in a product labeled as nut-free.

    Product
    IDLife Kids Bar Chocolate and Mixed Berry (SKU 16-0013) Organic, non-GMO, gluten-free and nut-free snack bar for children. Individually wrapped bars, packaged 10 to a box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0973-2018·2018-04-04

    J.M. Rosen's Cheesecake Recalled Due to Foreign Object Contamination

    J.M. Rosen's is recalling New York Traditional Cheesecake after a retail employee found a small rubber object in the product.

    Product
    J.M. Rosen's Cheesecake - New York Traditional; 6 - Unit- 4/46 oz in a case box; Product #56378 UPC 6 93892 99462 7; INGREDIENTS: Cream Cheese (Pasteurized Nonfat Milk, and Milkfat~ Whey Protein Concentrate, Cheese Culture. Salt, Whey, Stabilizers (Xanthan Gum, and/or…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0962-2018·2018-04-04

    Griffith Foods Recalls Toasted Italian Herbs Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Toasted Italian Herbs because a supplier recalled Autolyzed Yeast Powder due to Salmonella presence.

    Product
    Product Name Lot Number or ID Toasted Italian Herbs 661126
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1212-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound AC Adapter Recall for Fire Risk

    Konica Minolta is recalling 88 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage that may cause smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
    Category
    Medical Device
    Distribution
    35 states