The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6276–6300 of 26654

  • 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-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-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-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 (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
  • 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-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-1515-2025·2025-04-09

    Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect

    Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.

    Product
    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
    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 (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-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 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-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-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-1487-2025·2025-04-09

    GE Healthcare medical imaging systems security vulnerability could allow data access

    GE Healthcare Centricity imaging systems contain a security vulnerability where service login credentials can be identified. This could allow unauthorized access and potential patient data manipulation.

    Product
    GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-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 (Devices)·Z-1484-2025·2025-04-09

    GE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access

    GE Healthcare recalled Centricity PACS-IW and related medical imaging software due to a security vulnerability allowing service credentials to be identified, potentially enabling unauthorized system access and patient data manipulation.

    Product
    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1476-2025·2025-04-09

    Nasopore FD nasal dressing recalled for potential sterile barrier breach

    Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.

    Product
    Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1500-2025·2025-04-09

    Phoroptor VRx Digital Refraction System head may become loose or detach

    Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.

    Product
    Phoroptor VRx Digital Refraction System Model Numbers: 16241
    Category
    Medical Device
    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-1480-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Compromised Sterile Packaging Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.

    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