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.

11176–11200 of 27206

  • HighFDA (Devices)·Z-1913-2024·2024-06-05

    Mako Robotic Surgery Software Error May Delay Orthopedic Treatments

    Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0526-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2024·2024-06-05

    Mako 3.0 and 3.1 surgical systems software error causes treatment delays

    Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1280-2024·2024-06-05

    H-E-B Ice Cream Recalled for Potential Metal Contamination

    H-E-B Creamy Creations ice cream in 12-packs is being recalled due to potential metal contamination. Affected products have code dates from August 31 to September 3, 2024, and were distributed in Texas.

    Product
    3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1909-2024·2024-06-05

    Synchro Guide Wires Recalled for Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.

    Product
    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2024·2024-06-05

    BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk

    CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" Anesthesia Station ES, REF: 327
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1281-2024·2024-06-05

    H-E-B Chocolate Ice Cream recalled for potential metal contamination

    H-E-B Creamy Creations Chocolate Ice Cream 3-ounce 12-packs distributed in Texas are recalled due to potential metal contamination. Consumers should not consume the affected product.

    Product
    3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1271-2024·2024-06-05

    Mother's Day Heart Box Recalled for Undeclared Coconut Allergen

    Maribel's Sweets, Inc. is recalling its 7.7-piece Mother's Day heart box due to undeclared coconut. The product may pose a risk to consumers with coconut allergies. Approximately 4,011 boxes were distributed nationwide and through online retailers.

    Product
    7. 7pc Mother s Day heart box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2024·2024-06-05

    EYLEA injectable eye medication recalled due to sterility and syringe breakage

    Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.

    Product
    EYLEA — EYLEA (AFLIBERCEPT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0509-2024·2024-06-05

    Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers

    Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.

    Product
    CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1268-2024·2024-06-05

    Maribel's Sweets 6-piece ganache boxes recalled for undeclared coconut

    Maribel's Sweets, Inc. is recalling 4,011 boxes of 6-piece signature ganache chocolate boxes due to undeclared coconut. Consumers with coconut allergies are at risk.

    Product
    4. 6pc signature ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2024·2024-06-05

    BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

    The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2024·2024-06-05

    Pain Wizard topical pain relief recalled for manufacturing specification violation

    ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2024·2024-06-05

    Philips Hemodynamic Application software pressure wave data synchronization defect

    Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.

    Product
    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2024·2024-06-05

    Texas Pecan Co Mixed Nuts and Dried Fruits Recall for Allergen Cross-Contamination

    Texas Pecan Co is recalling mixed nuts and dried fruits due to potential cross-contamination with allergens including milk, soy, sesame, and wheat. Consumers with allergies to these allergens should not consume the affected products.

    Product
    1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds, Natural Sliced Almonds, Blanched Slivered Almonds, Blanched Whole Almonds and
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0518-2024·2024-06-05

    Cefdinir Oral Suspension recalled nationwide for defective container seals

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2024·2024-06-05

    Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2024·2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2024·2024-06-05

    FDA recalls Pain Wizard topical pain relief for ingredient specification issues

    ARG Laboratories recalled Pain Wizard topical pain relief roll-on due to active ingredient out of specification and violative-grade propylene glycol used in manufacturing.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2024·2024-06-05

    Mako robotic surgery system software error causes treatment delays

    Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0523-2024·2024-06-05

    Aloe Gator SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredients

    ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2024·2024-06-05

    Pain Wizard topical pain relief recalled for out-of-specification manufacturing

    ARG Laboratories recalls Pain Wizard pain relief cream nationwide due to manufacturing defect involving propylene glycol that did not meet specifications.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0508-2024·2024-05-29

    Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up

    Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.

    Product
    Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-1262-2024·2024-05-29

    Fresh soft white cheese recalled for potential Listeria contamination

    Tama Corporation is recalling Queso de mano (fresh soft white cheese) due to potential Listeria monocytogenes contamination. The affected product was distributed in Utah.

    Product
    Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1252-2024·2024-05-29

    Geissler's Supermarket Pink Lady Salmon Roll Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Pink Lady Salmon & Avo Roll Combo sushi due to undeclared egg allergen. Consumers with egg allergies risk allergic reactions if they consume this product.

    Product
    Geissler's Supermarket Pink Lady Salmon &Avo Roll Combo (sushi roll) Ingredients read in part: "***INGREDIENTS: SALMON, AVOCADO, WATER. NORI.WHITESTEAMEORICE. VINEGAR. SUGAR. SALT.LEMON.MIRIN. WASABI. GINGER. SOYSAUCE (WHEAT, SOYBEANS,ALCOHOL) HOT SAUCE: SUGAR. MAYO. CHILI, SRIR
    Category
    Food
    Distribution
    2 states