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.

8626–8650 of 52968

  • HighFDA (Food)·F-1277-2024·2024-06-05

    Texas Pecan Co Mixed Nuts Recalled for Potential Allergen Cross-Contamination

    Texas Pecan Co is recalling mixed nut and dried fruit products due to potential cross-contamination with milk, soy, sesame, wheat, tree nuts, and peanuts. Consumers with allergies 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
    1 state
  • 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-0517-2024·2024-06-05

    Metoprolol Tartrate Tablets Recalled Nationwide for Metal Contamination

    Rubicon Research is recalling 11,664 bottles of Metoprolol Tartrate 25mg tablets nationwide due to the presence of metal in the tablets. Consumers should discontinue use and contact their healthcare provider.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1265-2024·2024-06-05

    Ganache tote boxes recalled for undeclared coconut allergen

    Maribel's Sweets, Inc. is recalling 4,011 ganache tote boxes containing undeclared coconut. The product was distributed nationwide through e-commerce and retail stores in New York.

    Product
    1. 2pc Ganache tote box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2024·2024-06-05

    FDA Recalls Epinephrine-Lidocaine Intraocular Injections Due to Sterility Concerns

    Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1276-2024·2024-06-05

    Fresh N Lean Crustless Chicken Potato Pot Pie Recalled for Possible Listeria Contamination

    Nutrition Corp is recalling Fresh N Lean Crustless Chicken Potato Pot Pie due to possible Listeria monocytogenes contamination. The affected product was distributed nationwide with an expiration date of 5/08/2024.

    Product
    Fresh N Lean brand Crustless Chicken Potato Pot Pie. Packaged in plastic trays, vacuum sealed.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1273-2024·2024-06-05

    Mother's Day Heart Ganache Boxes Recalled for Undeclared Coconut

    Maribel's Sweets, Inc. is recalling Mother's Day heart ganache boxes because they contain undeclared coconut, an allergen not listed on the label. This poses a risk to consumers with tree nut allergies.

    Product
    9. 25pc Mother s Day heart ganache box
    Category
    Food
    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-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
    1 state
  • 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 (Devices)·Z-1896-2024·2024-06-05

    Philips Allura Xper FD10 system pivot brake failure after software update

    Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1892-2024·2024-06-05

    FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment

    The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.

    Product
    Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    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 (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
  • 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 (Drugs)·D-0529-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to the active ingredient being out of specification and improper grade propylene glycol being used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1283-2024·2024-06-05

    Veggies Made Great Frozen Breakfast Potato Bakes Recalled for Possible Listeria

    Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes are being recalled due to possible Listeria monocytogenes contamination. The frozen product was distributed to multiple western U.S. states.

    Product
    Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes. Net Wt. 36 OZ (2.25 LB) 1.02 KG. UPC: 70486300103. Frozen product. Individually wrapped in flowrap, 18 bakes per box.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1267-2024·2024-06-05

    Ganache candy boxes recalled nationwide for undeclared coconut allergen

    Maribel's Sweets is recalling 4,011 boxes of 4-piece ganache candy because they contain undeclared coconut, which poses an allergen risk to consumers with coconut allergies.

    Product
    3. 4pc ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1279-2024·2024-06-05

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

    H-E-B Creamy Creations Ice Cream is being recalled due to potential metal contamination. The 3-ounce 12-packs distributed in Texas with code dates 09/11/2024 through 09/21/2024 may be affected.

    Product
    3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack
    Category
    Food
    Distribution
    1 state
  • 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 (Devices)·Z-1917-2024·2024-06-05

    Centurion OB Instrument Tray Recalled for Detachable Needle Guide Component

    Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical procedures.

    Product
    Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2024·2024-06-05

    Dako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage

    Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.

    Product
    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2024·2024-06-05

    BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

    CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.

    Product
    BD Pyxis(TM) Anesthesia Station 4000, REF: 338
    Category
    Medical Device
    Distribution
    Distributed nationwide