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.

7701–7725 of 22103

  • HighFDA (Devices)·Z-1470-2025·2025-04-09

    Nasopore nasal dressing may have compromised sterile packaging

    Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.

    Product
    Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1506-2025·2025-04-09

    Medtronic A820 myPTM Infusion Pump Software Shows Delayed Patient Response

    Medtronic is recalling the A820 myPTM Software Application used with SynchroMed infusion pumps because the app is taking longer than expected to respond to patient interactions. Approximately 4365 units are affected worldwide.

    Product
    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall

    Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.

    Product
    Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
    Category
    Medical Device
    Distribution
    13 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
  • HighNHTSA·25V575000·2025-04-09

    [pending] 2025 JEEP WAGONEER S

    Pending LLM rewrite. Source: NHTSA 25V575000.

    Product
    JEEP — 2025 JEEP WAGONEER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-1472-2025·2025-04-09

    Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect

    Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.

    Product
    Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0306-2025·2025-04-09

    Biocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications

    Biocon Pharma is recalling 2,184 bottles of Atorvastatin Calcium Tablets USP 40 mg nationwide. The product failed to meet required dissolution specifications, which may affect medication absorption.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (Food)·F-0685-2025·2025-04-09

    SeaBear Clam Chowder Recalled for Potential Botulinum Contamination

    SeaBear Smokedhouse Alehouse Clam Chowder pouches are recalled nationwide due to potential seal failure that could allow Clostridium botulinum contamination. Consumers should not consume the product.

    Product
    SeaBear Smokedhouse Alehouse Clam Chowder is packaged in retort pouch, net wt. 12-oz., UPC 0 34507 07021 1. Case label, item 60104, Alehouse Chowder 12/CS.
    Category
    Food
    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-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 (Food)·F-0684-2025·2025-04-09

    SeaBear Salmon Chowder Recalled for Potential Seal Failure and Botulinum Risk

    SeaBear Smokedhouse Salmon Chowder is recalled due to potential seal failure that could allow Clostridium botulinum contamination. The recall affects 11,152 pouches distributed nationwide.

    Product
    SeaBear Smokedhouse Salmon Chowder is packaged in flexible retort pouch, net wt. 12-oz., UPC 0 34507 07001 3. Case label: Item 60077 Salmon Chowder 12/12oz, SeaBear/G&D Anacortes, WA.
    Category
    Food
    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 (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 (Devices)·Z-1511-2025·2025-04-09

    Cordis Vascular Stent System Recalled Due to Incorrect Product Size

    Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.

    Product
    Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0709-2025·2025-04-09

    Flaxseed Oil Dietary Supplement Recalled for Undeclared Soy Allergen

    Bioriginal Food & Science Corporation recalls Fresh Flax Oil OMEGA 3-6-9 due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.

    Product
    Fresh Flax Oil OMEGA 3-6-9 Organic Flaxseed Oil 16 Fl oz / 473 ml, Dietary Supplement, Black HDPE plastic bottle with cap, Manufactured for Natural Slim, San Juan Puerto Rico
    Category
    Food
    Distribution
    0 states
  • 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-0681-2025·2025-04-09

    Lean Cuisine Lemon Garlic Shrimp Stir Fry Recalled Due to Foreign Material

    Nestle-USA recalls Lean Cuisine Lemon Garlic Shrimp Stir Fry (10 oz) due to potential wood-like foreign material. Approximately 7,212 cases distributed across 37 states; check Batch Number 4214595511 (Best By September 2025).

    Product
    Lean Cuisine Lemon Garlic Shrimp Stir Fry, NET WT 10 OZ (283g), in a plastic tray with film seal, packaged inside a paperboard carton; 10 consumer units per case
    Category
    Food
    Distribution
    37 states
  • 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 (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
  • HighNHTSA·25V499000·2025-04-08

    2024-2025 Winnebago Ekko RV Tire Valve Extension Defect Recall

    Winnebago is recalling certain 2024-2025 Ekko recreational vehicles due to damaged tire valve extensions that can cause air loss in the inner tire and overload the outer tire, creating a crash risk. Dealers will replace the extensions free of charge.

    Product
    WINNEBAGO — 2024 WINNEBAGO EKKO
    Category
    Vehicle
    Distribution
    Distributed nationwide