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.

19301–19325 of 50410

  • HighFDA (Devices)·Z-2420-2021·2021-09-15

    Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure

    Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.

    Product
    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0956-2021·2021-09-15

    Fermentation Derived Pepsin recalled for undeclared egg allergen

    Ingredion is recalling Fermentation Derived Pepsin due to undeclared egg allergen. The affected product was distributed across multiple U.S. states.

    Product
    Fermentation Derived Pepsin Product packaging: 5 individual LDPE bags with a net weight of 5kg each and 2.5kg sample bags packaged in 25 kg HDPE Drums
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·21V714000·2021-09-15

    2022 Thomas Built Buses Saf-T-Liner HDX Recalled for Fan Belt Defect

    Daimler Trucks North America is recalling 50 model-year 2022 Thomas Built Buses Saf-T-Liner HDX school buses because fan drive pulley assembly bolts may be incorrect or improperly installed, potentially causing a disabled bus.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0959-2021·2021-09-15

    Trader Joe's Super Spinach Salad recalled for undeclared almonds

    Trader Joe's Super Spinach Salad packages were prepared using almonds instead of the declared pumpkin seeds, creating an undeclared allergen hazard for consumers with nut allergies.

    Product
    Trader Joe's Super Spinach Salad with Quinoa, carrots, cranberries, chickpeas, edamame, pumpkin seeds and a carrot ginger miso dressing. Net Wt. 10 oz. (284 g) Dressing and seeds/nuts are packed in separate clear pouches and visible to consumer. Contains: Soy UPC: 096155 SKU…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2423-2021·2021-09-15

    Arc Endocuff Vision endoscopic device recalled for packaging seal defects

    Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.

    Product
    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2021·2021-09-15

    Medical Device Test Kit Requires More Frequent Calibration Than Labeled

    Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2021·2021-09-15

    MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems

    Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21197·2021-09-15

    Gas One Propane Adapter Hoses Recalled for Fire Hazard

    Gas One is recalling about 19,500 propane adapter hoses because the hose can swell during use, causing gas to leak and posing a fire hazard. Gas One has received five reports of swelling with no injuries reported.

    Product
    Gas One propane adapter hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2021·2021-09-15

    Proteus 235 Proton Therapy System May Display Misleading Popup Message

    Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.

    Product
    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2021·2021-09-15

    Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator

    Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.

    Product
    Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V717000·2021-09-15

    Volvo Bus 9700 Recalled for Non-Compliant Headlight Output

    Volvo Bus is recalling 2008-2021 9700 vehicles because headlights may be too bright or dim, failing federal safety standards and increasing crash risk.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2021·2021-09-15

    COPAN FLOQSwabs Recalled Over Sterilization Integrity Failure

    Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.

    Product
    COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2021·2021-09-15

    Philips MRI System Tabletop May Not Fully Move in Manual Mode

    Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.

    Product
    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2021·2021-09-15

    MRI diagnostic device tabletop may not move completely in manual mode

    Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.

    Product
    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2021·2021-09-15

    Medical diagnostic kit requires more frequent calibration than Instructions stated

    The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V710000·2021-09-14

    Kaufman Equipment Trailer Recall for Defective Locking Mechanism

    Kaufman Trailers is recalling 2021 Equipment trailers because a defective locking mechanism may cause the trailer to detach from the vehicle, increasing crash risk.

    Product
    KAUFMAN — KAUFMAN EQUIPMENT TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E086000·2021-09-14

    UFP Distribution Recalls WIC RV LPG Change Over Regulators

    UFP Distribution LLC is recalling specific WIC RV LPG change over regulators that may fail and increase propane pressure, posing a fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21E085000·2021-09-13

    ZF Power Steering Pumps Recalled for Potential Loss of Assist

    ZF North America is recalling certain PS ED power steering pumps for Autocar and Spartan Fire vehicles due to a risk of losing power steering assist.

    Product
    STEERING:HYDRAULIC POWER ASSIST:PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V707000·2021-09-13

    2021 Audi E-Tron brake booster corrosion may disable braking systems

    Corrosion in the brake booster of certain 2021 Audi E-Tron vehicles may disable the Anti-Lock Brake System, Electronic Stability Control, and brake assist, increasing stopping distance and crash risk.

    Product
    AUDI — AUDI E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V708000·2021-09-13

    Keystone Hideout recreational vehicles recalled for propane regulator failure

    Certain 2020 Keystone Hideout recreational vehicles are recalled for faulty Winntec propane regulators that may fail and increase pressure, creating a fire risk in gas appliances. Dealers will replace the regulator free of charge.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN FUZION, BULLET, COLEMAN, KODIAK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09102021·2021-09-10

    FSIS Recalls Meat Snack Breadsticks Due to Misbranding and Undeclared Sesame Ingredient

    FSIS issued a public health alert for ready-to-eat breadsticks and meat and cheese snack packs from Jag Specialty Foods that were misbranded because sesame was not declared on the label.

    Product
    FSIS Issues Public Health Alert For Meat Snack Products Containing FDA-Regulated Breadstick Products That Have Been Recalled Due To Misbranding And An Undeclared Ingredient
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·21V702000·2021-09-10

    2022 GMC Acadia air bag system defect due to inactive safety module

    General Motors is recalling certain 2022 GMC Acadia vehicles with an unactivated sensing diagnostic module that prevents air bag deployment. The two affected units remain in dealer inventory.

    Product
    GMC — GMC ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide