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.

8526–8550 of 22105

  • HighFDA (Food)·F-0417-2025·2025-01-29

    Cal Yee Farms Fruit Basket Recalled for Undeclared Almonds

    Cal Yee Farms Fruit Basket (50-oz) is being recalled due to undeclared almonds. The product was distributed to 2 retail stores in California and through online and phone orders to California and Pennsylvania.

    Product
    Cal Yee Farms Fruit Basket (50-oz)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0973-2025·2025-01-29

    BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures

    BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 Main, REF 303
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0406-2025·2025-01-29

    Horizon Organic Aseptic Plain Whole Milk Recalled for Potential Premature Spoilage

    Horizon Organic Aseptic Plain Whole Milk may spoil before its expiration date. The recalled products were distributed in Arizona, California, and Nevada.

    Product
    Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 3663207127 (single unit). Distributed by: Danone US, LLC Broomfield, CO 80021. HOD (Horizon Organic Dairy) #: 140236
    Category
    Food
    Distribution
    0 states
  • HighCPSC·25102·2025-01-23

    Children's Holiday Pajama Sets recalled due to flammability violation

    Duluth Trading recalls about 22,400 children's holiday pajama sets that violate federal flammability regulations for sleepwear, posing a risk of burn injuries to children.

    Product
    Children's Holiday Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25103·2025-01-23

    NQDTPBOR Multi-Purpose Helmets Recalled Due to Head Injury Risk

    NQDTPBOR multi-purpose helmets for teens do not comply with federal bicycle safety standards for impact protection, stability, labeling, and certification. The recalled helmets, sold on Amazon from May to August 2024, can fail to protect wearers in a crash.

    Product
    NQDTPBOR Multi-Purpose Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25106·2025-01-23

    Teckwe Hair Dryer Brushes Recalled for Electrocution and Shock Hazard

    SHEIN Distribution is recalling about 310 Teckwe hair dryer brushes because they lack immersion protection, posing an electrocution or shock hazard if they fall into water while plugged in. No injuries have been reported.

    Product
    Teckwe Hair Dryer Brushes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2025·2025-01-22

    Nuclear Medicine Systems at Risk of Detector Fall During Transport

    Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.

    Product
    GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0835-2025·2025-01-22

    Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk

    Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.

    Product
    Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0949-2025·2025-01-22

    Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect

    Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2025·2025-01-22

    FDA Recalls Small Graptor Retractor Instruments Due to Cable Failures

    Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.

    Product
    8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2025·2025-01-22

    8MM Large Suturecut Needle Driver Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments due to frayed or broken grip cables. The recall affects 784 units distributed nationwide and internationally.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0852-2025·2025-01-22

    Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.

    Product
    8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0902-2025·2025-01-22

    VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement

    VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2025·2025-01-22

    Intuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.

    Product
    8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2025·2025-01-22

    Augustine HotDog Patient Warming Temperature Controller May Display Power-on Self-Test Error

    Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0893-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Detector Fall Risk

    GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.

    Product
    GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0895-2025·2025-01-22

    GE Healthcare Discovery NM/CT 670 Systems Risk of Detector Fall During Transport

    GE Healthcare's Discovery NM/CT 670 nuclear medicine imaging systems may have detectors that fall if not properly supported during transport or relocation, posing risk of life-threatening injury.

    Product
    GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0903-2025·2025-01-22

    Esteem Synergy Stomahesive Skin Barrier pre-cut wafers wrong size

    ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.

    Product
    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0943-2025·2025-01-22

    ECONO STERILE medical procedure kits recalled for potential sterile barrier breach

    Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2025·2025-01-22

    Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
    Category
    Medical Device
    Distribution
    0 states