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.

14151–14175 of 53090

  • HighCPSC·23137·2023-03-02

    TJX Office Chairs Recalled Due to Fall Hazard

    The TJX Companies is recalling approximately 81,700 office chairs because the back can break or detach from the seat base when occupied, posing a fall hazard. The firm has received 12 reports of the chair back failing, including 10 reports of injuries.

    Product
    Office Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23141·2023-03-02

    Helly Hansen Adult Workwear Sweatshirts and Hoodies Recalled for Burn Hazard

    Helly Hansen is recalling about 13,900 adult workwear sweatshirts and hoodies because they fail to meet federal flammability standards for clothing textiles, posing a risk of burn injuries.

    Product
    Adult workwear sweatshirts and hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V133000·2023-03-01

    Coachmen Motorhomes Recalled for Entry Door Latch Failure

    Forest River is recalling 2013 Coachmen Cross Country and 2023 Coachmen Sportscoach motorhomes because the entry door latch may fail, preventing entry or exit.

    Product
    COACHMEN — COACHMEN SPORTSCOACH, CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2023·2023-03-01

    Tohato Caramel Corn recalled for undeclared almond allergen

    Daiso California Warehouse is recalling Tohato Caramel Corn 5-packs because almond appears in the ingredient list but is missing from the allergen Contains statement. Consumers with almond allergies who rely on the allergen statement may unknowingly consume this product.

    Product
    Tohato 5packs of Caramel Corn 23g units UPC:4901940111145
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0403-2023·2023-03-01

    Cayenne Pepper Recalled for Elevated Aflatoxin Contamination

    Tampico Spice Company Inc is recalling Cayenne Pepper in 1-pound and 5-pound jars due to elevated aflatoxin levels. The affected lot is #2112245, distributed across eight states.

    Product
    Cayenne Pepper 1 pound jars, and 5 pound jars
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0348-2023·2023-03-01

    Warfarin Sodium Tablets Recalled Due to Failed Impurity and Degradation Specifications

    Rising Pharmaceuticals is recalling Warfarin Sodium Tablets USP 1 mg due to failed impurities and degradation specifications. Approximately 12,216 bottles may have been distributed nationwide.

    Product
    Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0358-2023·2023-03-01

    Gordon Choice Cranberry Orange Nut Muffin Batter Recalled for Undeclared Soy

    BAKE'N JOY FOODS is recalling Gordon Choice Cranberry Orange Flavored Nut muffin batter due to undeclared soy lecithin. Consumers with soy allergies face a reaction risk.

    Product
    Gordon Choice Cranberry Orange Flavored Nut muffin batter; 8lbs; packaged in pails
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1166-2023·2023-03-01

    Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk

    Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.

    Product
    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2023·2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.

    Product
    Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1159-2023·2023-03-01

    IV Start Kit Recalled Due to Connector Manufacturing Defect

    Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.

    Product
    Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1156-2023·2023-03-01

    HydroMID 4Fr Peripheral Venous Catheter Kit Recalled for Incorrect Component Labeling

    Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.

    Product
    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0404-2023·2023-03-01

    Cajun Seasoning recalled for elevated aflatoxin levels

    Tampico Spice Company is recalling Cajun Seasoning in multiple sizes due to elevated aflatoxin contamination. Affected lots were distributed across eight states.

    Product
    Cajun Seasoning 1 OZ, 1 LB, 1.5 LBS, 2 LBS, 5 LBS, 6 LBS units
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0339-2023·2023-03-01

    Levothyroxine sodium oral solution recalled due to subpotency

    IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2023·2023-03-01

    Medline Sterile Hand Pack recalled for inadequate sterilization

    Medline Sterile Hand Pack surgical prep kits are recalled because components were improperly placed in the nonsterile portion of the tray and did not receive proper sterilization. Affects 1,689 trays distributed in AR, CO, and GA.

    Product
    (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2023·2023-03-01

    Diagnostic imaging system recalled due to ceiling and wall collision risk

    Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.

    Product
    Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2023·2023-03-01

    Siemens Atellica IM Folate 700 test kit recalled for measurement bias

    Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.

    Product
    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2023·2023-03-01

    Diagnostic folate test kits recalled for negative measurement bias

    Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.

    Product
    ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0331-2023·2023-03-01

    Prescription drug TIROSINT levothyroxine recalled for subpotent formulation

    IBSA Pharma has recalled two lots of TIROSINT levothyroxine sodium oral solution nationwide because they contain less active ingredient than labeled. The affected lots are 220409 (expiring 10/2023) and 220956 (expiring 03/2024).

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2023·2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.

    Product
    Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0342-2023·2023-03-01

    FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency

    IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2023·2023-03-01

    TIROSINT Levothyroxine Sodium Oral Solution Recalled for Subpotency

    TIROSINT (levothyroxine sodium) oral solution has been recalled nationwide by IBSA Pharma Inc. due to subpotency, with the affected medication containing less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2023·2023-03-01

    Siemens Atellica IM Folate 140 test kit recalled for measurement bias

    Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.

    Product
    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2023·2023-03-01

    Sodium Chloride Injection Recalled for Incomplete Seal and Potential Leakage

    B. Braun Medical is recalling 0.9% Sodium Chloride Injection due to possible incomplete container seals that may leak. The recall involves 483,229 bags distributed nationwide.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0334-2023·2023-03-01

    Levothyroxine oral solution TIROSINT recalled nationwide for subpotency

    IBSA Pharma voluntarily recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency concerns. Affected lots are 220416 (Exp. 10/2023) and 221053 (Exp. 4/2024).

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide