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.

2001–2025 of 52931

  • HighFDA (Drugs)·D-0324-2026·2026-02-18

    Testosterone 200mg single pellets recalled over potential metal particulate

    Asteria Health is recalling 194,336 pellets of Testosterone, 200 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0319-2026·2026-02-18

    Testosterone 37.5mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 60,868 pellets of Testosterone, 37.5 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2026·2026-02-18

    Azurion 3 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 291 units of the Azurion 3 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0495-2026·2026-02-18

    Spicy breakfast burritos recalled over small hard plastic fragments

    MG Foods-Compass Group is recalling 3,099 Spicy Breakfast Burritos, 10 oz, over foreign material described as small hard plastic fragments.

    Product
    Spicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·H-0503-2026·2026-02-18

    Peanut butter and grape jelly packs recalled over blue plastic

    Ventura Foods is recalling 929 cases of 2.12oz packs after the firm found pieces of blue plastic in a filter during production.

    Product
    CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328 CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g)/GRAPE JELLY NET WT 1 OZ (28g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1351-2026·2026-02-18

    Azurion 5 M20 systems recalled over tables that may move unexpectedly

    Philips is recalling 922 units of the Azurion 5 M20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0309-2026·2026-02-18

    Estradiol 12.5mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 22,478 pellets of ESTRADIOL, 12.5 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0310-2026·2026-02-18

    Estradiol 15mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 14,848 pellets of ESTRADIOL, 15 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2026·2026-02-18

    Azurion 7 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 1 of the Azurion 7 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2026·2026-02-18

    Testosterone 87.5mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 62,581 pellets of Testosterone, 87.5 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2026·2026-02-18

    Testosterone 75mg and anastrozole pellets recalled over metal particulate matter

    Asteria Health is recalling 670 pellets of Testosterone 75mg, Anastrozole 4mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2026·2026-02-18

    IQon Spectral CT recalled over rotor fasteners that may be undertorqued

    Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

    Product
    IQon Spectral CT; Product Code (REF): 728332;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0311-2026·2026-02-18

    Estradiol 18mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 1,699 pellets of ESTRADIOL, 18 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2026·2026-02-18

    Surgeon console displays recalled over firmware that can lose visualization

    Intuitive Surgical is recalling 47 da Vinci 5 Surgeon Console Viewer Displays manufactured with outdated firmware, which may cause loss of the 3D surgical field or complete visualization loss.

    Product
    da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2026·2026-02-18

    Azurion 5 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 326 units of the Azurion 5 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2026·2026-02-18

    Vascular access kits and trays recalled over open swabstick seals

    Medline is recalling 21,854 units of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0505-2026·2026-02-18

    Besan laddoo recalled because milk is undeclared in the ingredient statement

    Karison Foods & Snacks is recalling 230 cases of Karison brand Besan Laddoo, 12 oz, because the product contains milk which is undeclared in the ingredient statement.

    Product
    Karison brand BESAN LADDOO; NET WT. 12 oz.; Ingredients: Gram Flour, Butter, Sugar, Zero Trans Fat Vegetable Shortening, Almonds, Cardamom; UPC: 8 9730700240 6; Distributed By: Karson Foods & Snacks Inc., 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility t
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1333-2026·2026-02-18

    Blood culture kits recalled over open swabstick applicator seals

    Medline is recalling 4,300 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2026·2026-02-18

    Anesthesia artline packs recalled over open swabstick applicator seals

    Medline is recalling 120 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2026·2026-02-18

    Breast biopsy needles recalled over particulates that can enter tissue

    Hologic is recalling 681,870 Brevera Breast Biopsy System disposable 9 gauge needles because particulates in affected devices can be deposited into breast tissue during use.

    Product
    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0320-2026·2026-02-18

    Testosterone 50mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 70,959 pellets of Testosterone, 50.0 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0314-2026·2026-02-18

    Estradiol 25mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 2,442 pellets of ESTRADIOL, 25 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2026·2026-02-18

    Estradiol 6mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 50,990 pellets of ESTRADIOL, 6 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
    Category
    Drug
    Distribution
    Distributed nationwide