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.

4751–4775 of 52939

  • HighFDA (Devices)·Z-1486-2025·2025-04-09

    GE Healthcare Cardiology CA1000 Security Vulnerability Could Allow Patient Data Access

    GE Healthcare Centricity Cardiology CA1000 has a security vulnerability where service login credentials can be identified, potentially allowing unauthorized access to patient data.

    Product
    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MAN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1509-2025·2025-04-09

    BD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market

    BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.

    Product
    BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1474-2025·2025-04-09

    Nasopore nasal dressing recall: compromised sterile barrier seals

    Stryker recalls Nasopore 4cm fragmentable nasal dressings due to potential blister seal damage that compromises the sterile barrier. Nationwide distribution affected.

    Product
    Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2025·2025-04-09

    Stryker Monterey AL Implant Inserter Gold Button Detachment Risk

    Stryker Spine is recalling Monterey AL Implant Inserters due to a potential defect where the gold unlock button may separate from the device, compromising its function during spinal surgery.

    Product
    Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1471-2025·2025-04-09

    Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects

    Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.

    Product
    Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2025·2025-04-09

    Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect

    Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.

    Product
    Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0693-2025·2025-04-09

    Good & Gather Baby Vegetable Puree Recalled for Elevated Lead Levels

    Good & Gather baby vegetable puree (4 oz) is being recalled due to elevated levels of lead. The recall affects 25,600 units distributed nationwide by Target.

    Product
    Good & Gather baby Pea, Zucchini, Kale & Thyme Vegetable Puree. Net Wt 4 oz. (113g). 6+ months. UPC 1 91907-99314 1. Distributed by Target Corporation, Minneapolis, MN 55403. Product of Colombia
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2025·2025-04-09

    Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0687-2025·2025-04-09

    Julie's Gorditas De Nata Recalled for Undeclared Wheat Allergen

    Julie's Gorditas De Nata is being recalled because the product label fails to declare wheat as an ingredient, posing a risk to consumers with wheat allergies. The recall affects 240 units distributed to two wholesalers.

    Product
    Julie's Gorditas De Nata; Ingredients: Flour, Vegetable Oil, Sugar, Baking Soda, Milk, Sour Cream, Butter, Cream Of Milk, Cinnamon, Vanilla; Net Wt. 16.75 OZ UPC# 0 00202 12018 6
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0690-2025·2025-04-09

    CraftMark Oatmeal Cranberry Raisin Cookie Dough Recalled for Plastic Contamination

    Craftmark Bakery is recalling CraftMark Oatmeal Cranberry Raisin Cookie Dough due to potential plastic contamination. The recall affects 119 cases distributed in California, Illinois, Maryland, and Canada.

    Product
    5000642 CraftMark Oatmeal Cranberry Raisin Cookie Dough, 8 poly bags of 18 frozen pucks in a corrugate case, Net Weight 27.00 lb
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0683-2025·2025-04-09

    Lean Cuisine Ravioli Recalled Due to Potential Wood-Like Foreign Material

    Nestle USA is recalling Lean Cuisine Spinach Artichoke Ravioli due to potential wood-like foreign material in the product. The affected 9-ounce frozen meals were distributed across 33 states.

    Product
    Lean Cuisine Spinach Artichoke Ravioli, NET WT 9 OZ (255g), in a plastic tray with film seal, packaged inside a paperboard carton; packed 12 consumer units per case
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0674-2025·2025-04-09

    Kashk Whey Product Recalled for Undeclared Milk Allergen

    Nader Trading, Inc. is recalling Kashk (whey) products because the product label fails to include milk in the ingredient listing. The recall affects products distributed in Maryland, Virginia, and California.

    Product
    Kashk (Whey) Ingredients: Whey, Water, Salt Nader Trading Inc., 1821 E. Dryer Road, Santa Ana, CA 92705 UPC# 685357001537
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·25V225000·2025-04-09

    Audi Q6 e-tron rearview cameras may show a blurry image

    Volkswagen is recalling certain 2025 Audi Q6 e-tron and SQ6 e-tron vehicles because the rearview camera may show a blurry image, failing FMVSS 111.

    Product
    AUDI — AUDI Q6 E-TRON, SQ6 SPORTBACK E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V226000·2025-04-09

    Audi Q6 rearview camera image may be delayed or deactivated

    Volkswagen is recalling certain 2025 Audi Q6 and SQ6 vehicles because the rearview camera image may be delayed or deactivated after shifting into reverse, failing FMVSS 111.

    Product
    AUDI — AUDI SQ6 SPORTBACK E-TRON, Q6 E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0686-2025·2025-04-09

    Turkey BLT Sandwiches Recalled for Undeclared Peanut Allergen

    The Coastal Companies is recalling Turkey BLT on Sourdough sandwiches because some packages contain incorrectly labeled Peanut Butter & Jelly sandwiches instead, exposing consumers to an undeclared peanut allergen.

    Product
    Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1502-2025·2025-04-09

    Diagnostic reagent recalls incorrect ISI value on Pacific Hemostasis Thromboplastin-D

    Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D due to an incorrect International Sensitivity Index (ISI) value printed on the outer box label. The error could affect interpretation of prothrombin time test results.

    Product
    Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1517-2025·2025-04-09

    Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0689-2025·2025-04-09

    Oatmeal Raisin Cookie Dough Recalled for Potential Plastic Contamination

    Craftmark Bakery, LLC is recalling approximately 90 cases of 5000108 Oatmeal Raisin Cookie Dough due to potential plastic foreign material contamination. The affected product was distributed to California, Illinois, Maryland, and Canada.

    Product
    5000108 OATMEAL RAISIN COOKIE DOUGH, 6 poly bags of 30 frozen pucks in a corrugate case, Net Weight: 8.67 kg (19.12 lb)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1491-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation

    Stryker Spine is recalling the Monterey AL Implant Inserter (22mm, Catalog 48019140) due to potential separation of the gold unlock button from the device. The recall affects 41 units in the United States and 3 internationally.

    Product
    Monterey AL Implant Inserter; 22mm; Catalog 48019140.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1483-2025·2025-04-09

    GE Healthcare Medical Imaging Software Vulnerability Allows Unauthorized System Access

    GE Healthcare's Centricity medical imaging software has a security vulnerability that allows service login credentials to be identified. A malicious actor could exploit this to access or manipulate patient data.

    Product
    GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1514-2025·2025-04-09

    Ethicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect

    Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.

    Product
    PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0308-2025·2025-04-09

    Prescription Duloxetine Capsules Recalled for Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling Duloxetine 30 mg capsules distributed nationwide due to a nitrosamine impurity above acceptable limits. Consumers should consult their doctor about their medication.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2025·2025-04-09

    Phoroptor VRx Digital Refraction System Recalled for Detachable Head

    Reichert is recalling 1,876 units of the Phoroptor VRx Digital Refraction System (Model 16242) due to an assembly defect that could cause the refraction head to detach during eye examinations.

    Product
    Phoroptor VRx Digital Refraction System Model Numbers: 16242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Breached Sterile Packaging

    Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.

    Product
    Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0682-2025·2025-04-09

    Lean Cuisine Butternut Squash Ravioli Recalled for Potential Foreign Material

    Nestle-USA recalls Lean Cuisine Butternut Squash Ravioli for potential wood-like foreign material. Approximately 50,611 cases distributed across 36 states are affected.

    Product
    Lean Cuisine Butternut Squash Ravioli, NET WT 9 7/8 OZ (280g), in a plastic tray with film seal, packaged inside a paperboard carton; packed 12 consumer units per case
    Category
    Food
    Distribution
    37 states