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.

26–50 of 52881

  • HighFDA (Devices)·Z-3026-2026·2026-09-02

    Medline C-Section Convenience Kits Recalled for Contaminated Components

    Medline Industries is recalling 106 C-section convenience kits distributed nationwide due to potentially contaminated components.

    Product
    Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3020-2026·2026-09-02

    Medline Recalls 263 Surgical Convenience Kits Due to Contamination

    Medline Industries is recalling 263 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide in 18 states.

    Product
    Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2994-2026·2026-09-02

    Medline Medical Convenience Kits Recalled for Endotoxin Levels

    Medline Industries is recalling 2,262 medical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.

    Product
    Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3033-2026·2026-09-02

    IMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk

    IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.

    Product
    ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0780-2026·2026-09-02

    Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets

    Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 112 mcg tablets because they are subpotent. The recall covers nationwide distribution.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3012-2026·2026-09-02

    Midmark IQecg Digital ECG Software Recall for Inaccurate Waveforms

    Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.

    Product
    Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3028-2026·2026-09-02

    Medline Recalls 419 Surgical Kits Due to Contaminated Component

    Medline Industries is recalling 419 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide.

    Product
    Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2998-2026·2026-09-02

    Hollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect

    Hollister is recalling specific lots of Onli hydrophilic urethral intermittent catheters because a manufacturing defect may cause a protrusion that leads to genitourinary trauma or bleeding.

    Product
    Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; 2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; 3) 82121 Ch12-17 Onli Hydrophilic Urethral In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0782-2026·2026-09-02

    Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide

    Accord Healthcare is recalling specific lots of Levothyroxine Sodium 137 mcg tablets because they may contain less than the labeled amount of active ingredient.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1274-2026·2026-09-02

    Lidl Recalls Eridanous Greek Style Shortbread Cookies Due to Undeclared Allergens

    Lidl US Trading is recalling Eridanous Greek Style Shortbread Cookies because the labels contain only foreign languages and fail to declare wheat, soy, milk, eggs, and coconut.

    Product
    ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125839.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-3038-2026·2026-09-02

    GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss

    GE Medical Systems is recalling 15 units of Portrait Core Services Software V1.0.5 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.

    Product
    PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·H-1275-2026·2026-09-02

    Lidl Recalls Eridanous Greek Style Shortbread Cookies for Undeclared Allergens

    Lidl US Trading is recalling 200 units of Eridanous Greek Style Shortbread Cookies because the labels contain only foreign languages and fail to declare wheat, soy, milk, eggs, and coconut.

    Product
    ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125846.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-3021-2026·2026-09-02

    Medline Head and Neck Kits Recalled for Contaminated Component

    Medline is recalling 24 convenience kits labeled as MAJOR HEAD AND NECK PPS because they contain a potentially contaminated component.

    Product
    Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2992-2026·2026-09-02

    Medline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage

    Medline is recalling 145,525 neonatal and infant heated wire breathing circuits due to potential thermal damage that could cause airway obstruction.

    Product
    Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2996-2026·2026-09-02

    Medline Neurosponge Kits Recalled for Endotoxin Levels

    Medline is recalling 3,468 neurosurgical convenience kits containing Pilling Wecksorb Neurosponges due to potential out-of-specification endotoxin levels.

    Product
    Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3027-2026·2026-09-02

    Medline Recalls Surgical Convenience Kits Due to Contaminated Components

    Medline Industries is recalling 169 surgical convenience kits nationwide because they contain potentially contaminated components.

    Product
    Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2026·2026-09-02

    Medline Recalls 71 Convenience Kits Due to Contaminated Component

    Medline Industries is recalling 71 FEMORAL PACK and FEVAR convenience kits because they contain a potentially contaminated component.

    Product
    Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3037-2026·2026-09-02

    GE Medical Systems Recalls Portrait Compute and Core Services Software

    GE Medical Systems is recalling 4 units of Portrait Compute and Core Services V1.2 software due to a defect that may cause loss of patient monitoring and reset alarm settings to factory defaults.

    Product
    PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-3023-2026·2026-09-02

    Medline Convenience Kits Recalled for Potentially Contaminated Component

    Medline Industries is recalling 15 convenience kits (SKU CDS980375M) due to a potentially contaminated component. The kits were distributed in 18 US states.

    Product
    Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1271-2026·2026-09-02

    Kettle Cuisine Recalls Marketside Tomato Bisque Soup Kit for Listeria

    Kettle Cuisine is recalling Marketside Tomato Bisque Soup Kits due to a presumptive positive test for Listeria monocytogenes.

    Product
    Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-3004-2026·2026-09-02

    Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements

    Merge Healthcare is recalling 20 Merge PACS and Merge OrthoPACS workstations because a software issue may cause measurements to be displayed inaccurately.

    Product
    Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1277-2026·2026-09-02

    Byron White Herbal Supplement Recalled for Undeclared Walnut Allergen

    Byron White Formulas is recalling its A-P Herbal Supplement because the label fails to declare walnuts in English, posing a risk to individuals with nut allergies.

    Product
    Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-2995-2026·2026-09-02

    Medline Medical Convenience Kits Recalled for Endotoxin Levels

    Medline is recalling 246 surgical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.

    Product
    Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
    Category
    Medical Device
    Distribution
    Distributed nationwide