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.

51–75 of 50460

  • HighFDA (Devices)·Z-3295-2026·2026-10-07

    Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits

    Cardinal Health is recalling 3,677 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because handpieces may leak fluid, creating a slip and fall hazard.

    Product
    Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3304-2026·2026-10-07

    Heraeus Medical Recalls PALACOS MV Pro Bone Cement Due to Leakage Risk

    Heraeus Medical is recalling PALACOS MV pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall covers all lot numbers distributed worldwide.

    Product
    PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2026·2026-10-07

    United Imaging uCT 530 CT Systems Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 530 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3275-2026·2026-10-07

    Bard EnCor EnCompass Breast Biopsy System Software Recall

    Bard Peripheral Vascular Inc is recalling 99 EnCor EnCompass Breast Biopsy and Tissue Removal Systems due to software errors that may interrupt procedures.

    Product
    EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1402-2026·2026-10-07

    Lior Cinnamon Ground Seasoning Recalled for Elevated Lead Levels

    Galil Importing Corp is recalling Lior brand Cinnamon Ground Seasoning due to elevated lead levels. The product was distributed in six states.

    Product
    Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-3305-2026·2026-10-07

    Embosphere Microspheres Recalled Due to Packaging Sterility Concerns

    Merit Medical Systems is recalling Embosphere microspheres because packaging holes may compromise sterility, posing an infection risk.

    Product
    Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3271-2026·2026-10-07

    Alere hCG Pregnancy Test Cassettes Recalled for False Positive Results

    Alere San Diego is recalling hCG rapid test cassettes because they may detect low hormone levels, leading to false positive pregnancy results.

    Product
    McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3323-2026·2026-10-07

    Percussionaire Impulsator and Phasitron 5 Recall for Anesthesia Warning Update

    Percussionaire Corporation is recalling Impulsator and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.

    Product
    Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3330-2026·2026-10-07

    Tandem t:slim iOS App Recall Due to CGM Pairing Failure

    Tandem Diabetes Care is recalling a beta version of its t:slim iOS app because it fails to pair with Abbott FreeStyle Libre 3 Plus sensors, forcing users into manual mode.

    Product
    Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3335-2026·2026-10-07

    Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica CH Revised C-Reactive Protein reagent due to the potential for falsely elevated test results.

    Product
    Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3289-2026·2026-10-07

    FDA Recalls Performance Pro Nitrile Gloves Due to Defects

    American Nitrile Operations is recalling Performance Pro blue nitrile gloves due to defects like tears and debris that may expose users to pathogens or chemicals.

    Product
    Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1401-2026·2026-10-07

    Organiccs Collagen Peptides Recalled for Undeclared Shellfish Ingredient

    Pacific Health Sciences is recalling Organiccs collagen supplements due to undeclared crab shell, a shellfish allergen.

    Product
    Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for Strengthening Hair, Skin, Nails, Muscles & Joints, 180 Veggie Capsules. UPC: none
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-3274-2026·2026-10-07

    Alere San Diego Recalls hCG Urine Pregnancy Tests for False Positives

    Alere San Diego is recalling multiple hCG urine pregnancy test models because they may detect low hCG levels, resulting in false positive results.

    Product
    Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3306-2026·2026-10-07

    NOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect

    NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to a manufacturing issue that may cause irregular oxygen readings.

    Product
    NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3320-2026·2026-10-07

    Percussionaire In-Line Valve Recalled for Anesthetic Delivery Warning

    Percussionaire Corporation is recalling 98,434 In-Line Valves to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.

    Product
    In-Line Valve, Product Number: P5-TEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3303-2026·2026-10-07

    Heraeus Medical Recalls PALACOS MV+G Pro Bone Cement Due to Leakage

    Heraeus Medical is recalling PALACOS MV+G pro 40 and 80 bone cement due to potential monomer liquid leakage. The recall affects 20,523 units distributed worldwide.

    Product
    PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3334-2026·2026-10-07

    Wright Medical Recalls Charlotte Claw Screws Due to Missing Threads

    Wright Medical Technology is recalling 34 Charlotte Claw Screws because missing threads on the screwheads may prevent secure engagement with the plate, potentially prolonging surgery.

    Product
    CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3290-2026·2026-10-07

    FDA Recalls Defective Blue Nitrile Patient Examination Gloves

    American Nitrile Operations LLC is recalling 36.8 million Opportunity Flex blue nitrile gloves due to defects like tears and debris that may expose users to pathogens or chemicals.

    Product
    Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1400-2026·2026-10-07

    Cloud Cafe Collagen Milk Recalled for Undeclared Fish Allergen

    TOJI CO. is recalling Cloud Cafe Collagen Milk due to an undeclared fish allergen. The product was sold to a single distributor in Los Angeles.

    Product
    Cloud Cafe branded Collagen Milk; Strawberry Milk Zero; Caffeine Free; 10pc/box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0878-2026·2026-10-07

    SV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination

    SV Labs Toronto Corporation is recalling specific lots of Benzoyl Peroxide Wash, USP, 5% due to microbial contamination. The product was distributed in Illinois.

    Product
    Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-3297-2026·2026-10-07

    Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage

    Cardinal Health 200, LLC is recalling 2,957 gynecological laparoscopy kits because the handpieces may leak fluid, creating a slip and fall hazard.

    Product
    Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3298-2026·2026-10-07

    Cardinal Health Recalls Presource Packs with Leaking Handpieces

    Cardinal Health 200, LLC is recalling 22 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because the handpieces may leak fluid, creating a slip and fall hazard.

    Product
    Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3292-2026·2026-10-07

    FDA Recalls Medical Kits with Contaminated Pericare Wipes

    American Contract Systems Inc. is recalling medical convenience kits containing BD CliniClean Pericare Wipes due to potential lubricant contamination.

    Product
    Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V657000·2026-10-06

    KME Recalls 2024 CV515 SFA 4x4 and Severe Service Emergency Vehicles

    KME is recalling 2024 CV515 SFA 4x4 and Severe Service emergency vehicles because a node may become unresponsive, causing loss of exterior lighting and pump-mode functionality.

    Product
    KME — KME CV515 SFA 4X4, SEVERE SERVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide