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.

7626–7650 of 22060

  • 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
    0 states
  • 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 (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-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-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 (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 (Devices)·Z-1504-2025·2025-04-09

    Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results

    Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.

    Product
    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
    Category
    Medical Device
    Distribution
    12 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-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-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-1473-2025·2025-04-09

    Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals

    Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.

    Product
    Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2025·2025-04-09

    Nasal dressing recall: potential sterile barrier breach from seal defect

    Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.

    Product
    Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0691-2025·2025-04-09

    Craftmark Bakery Recalls Monster Cookies Due to Potential Plastic Contamination

    Craftmark Bakery is recalling US Foods Premium Monster Cookies due to potential plastic contamination. Consumers should not consume affected products.

    Product
    US Foods PREMIUM MONSTER COOKIE, 3 0Z Individually Poly film wrapped Ready to eat cookies, UPC 7 67367 10341 5. 52 Individually Poly film wrapped Ready to eat cookies per case, case UPC 10767367103412
    Category
    Food
    Distribution
    3 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 (Food)·F-0719-2025·2025-04-09

    Chocolate Spread Recalled: CACAO BARRY Gianduja Noir Contains Undeclared Milk

    CACAO BARRY Gianduja Noir chocolate product is recalled due to undeclared milk, affecting 180 cases distributed across eight states. Consumers with milk allergies should not consume this product.

    Product
    CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case.
    Category
    Food
    Distribution
    8 states
  • 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
  • HighNHTSA·25V576000·2025-04-09

    Jeep Grand Cherokee Plug-In Hybrid Software Error Causes Loss of Drive Power

    Chrysler recalls certain 2022-2026 Jeep Grand Cherokee plug-in hybrids for a software error in the hybrid control processor that may cause loss of drive power and increase crash risk.

    Product
    JEEP — 2023 JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-1469-2025·2025-04-09

    Otopore Outer Ear Dressings Recalled for Compromised Sterile Packaging Seals

    Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.

    Product
    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
    Category
    Medical Device
    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 (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-1477-2025·2025-04-09

    Hemopore nasal wound dressing packaging seal defect may compromise sterility

    Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.

    Product
    Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
    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