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.

1301–1325 of 52929

  • HighFDA (Drugs)·D-0452-2026·2026-04-22

    FarmHouse Fresh benzoyl peroxide night lotion recalled over benzene contamination

    FarmHouse Fresh Midnight Clearing Night Lotion, a 2.5% benzoyl peroxide acne treatment, is being recalled because of chemical contamination from the presence of benzene.

    Product
    FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2026·2026-04-22

    Bupivacaine spinal ampules recalled nationwide over lack of sterility assurance

    Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP ampules are being recalled for lack of assurance of sterility. The action covers 3,260,170 ampules.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·26V259000·2026-04-22

    Trails West RPM Freeride Recalled for Cooktop Flame Fire Risk

    Trails West is recalling 2027 RPM Freeride recreational trailers because the cooktop flame may invert during furnace operation, increasing fire risk.

    Product
    TRAILS WEST — TRAILS WEST RPM FREERIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0681-2026·2026-04-22

    Pure Palm Medjool dates packaging carries the wrong product label

    Pure Palm Medjool Dates are being recalled because coconut-covered date bites were packed in containers labelled for regular date bites. 50 cases are affected.

    Product
    Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0532-2026·2026-04-22

    Huons lidocaine 2% injection recalled over lack of sterility assurance

    Lidocaine HCl Injection, USP 2% in 5 mL single-dose vials manufactured by Huons is being recalled for lack of assurance of sterility. All lots within expiry are affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2026·2026-04-22

    Instinct Plus endoscopic clipping devices may malfunction during use

    The Instinct Plus Endoscopic Clipping Device is being recalled after increased complaints indicating the device has the potential to malfunction. 713,702 units are affected.

    Product
    Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2026·2026-04-22

    Cytal Wound Matrix recalled over out-of-specification endotoxin test results

    Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2026·2026-04-22

    Cytal Burn Matrix recalled over out-of-specification endotoxin test results

    Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.

    Product
    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2026·2026-04-22

    Yeastone Broth recalled because it may report incorrect susceptibility results

    Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0665-2026·2026-04-22

    Booey's Dragon's Breath sauce omits fish and sesame from contains statement

    Booey's Dragon's Breath sauce is being recalled because the ingredients statement declares anchovy and sesame but the contains statement does not declare fish and sesame.

    Product
    Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Wat
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1822-2026·2026-04-22

    Cellex photopheresis kit centrifuge bowls may dislodge and break

    Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.

    Product
    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2026·2026-04-22

    Centurion circumcision kits distributed without the required sterilization process

    Medline is recalling one lot of Centurion Circumcision Kits that was distributed without undergoing the required sterilization process and is therefore not sterile. 640 kits are affected.

    Product
    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2026·2026-04-22

    Elegance anterior cervical plates recalled over burrs on finished product

    Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.

    Product
    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" So
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2026·2026-04-22

    Arjo Tenor patient lift actuators may lose the ability to hold load

    Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.

    Product
    Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2026·2026-04-22

    Skin Script blemish spot treatment recalled for failing stability specifications

    Skin Script Blemish Spot Treatment containing 1% salicylic acid is being recalled after it failed stability specifications. The action covers 28,163 bottles.

    Product
    Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2026·2026-04-22

    ARTIS Pheno 3D acquisitions may capture uneven patient image brightness

    ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.

    Product
    ARTIS Pheno VE30A and VE40A, Model 10849000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0455-2026·2026-04-22

    SLMD benzoyl peroxide acne lotion recalled over benzene contamination

    SLMD Benzoyl Peroxide Acne Lotion, 2.5% benzoyl peroxide, is being recalled because of chemical contamination from the presence of benzene. 2,500 bottles are affected.

    Product
    SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2026·2026-04-22

    Philips Spectral CT on Rails recalled over three software issues

    Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.

    Product
    Philips Spectral CT on Rails. Model Number: 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2026·2026-04-22

    Gentuity HF-OCT imaging systems may repeat frames during catheter pullback

    Gentuity is issuing a correction for HF-OCT Imaging Systems because frames may repeat during pullback with Vis-Rx catheters, affecting longitudinal length measurements.

    Product
    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
    Category
    Medical Device
    Distribution
    Distributed nationwide