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.

8601–8625 of 52968

  • HighFDA (Devices)·Z-1902-2024·2024-06-05

    Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing

    Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.

    Product
    Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2024·2024-06-05

    BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

    BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

    Product
    BD Pyxis MedStation ES, REF: 323, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2024·2024-06-05

    Captus 4000e Thyroid Uptake System recalled for unexpected collimator detachment

    Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.

    Product
    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2024·2024-06-05

    RefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error

    Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
    Category
    Medical Device
    Distribution
    6 states
  • 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 (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 (Devices)·Z-1898-2024·2024-06-05

    Radiographic imaging system tubes may fall due to bolt rupture

    FUJIFILM's FDR Visionary Suite radiographic imaging system has bolts that may rupture due to fatigue, potentially causing the tube support to fall and injure patients. The recall affects 18 units distributed across nine states.

    Product
    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
    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 (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 (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-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 (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 (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-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    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-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 (Devices)·Z-1905-2024·2024-06-05

    Trevo NXT neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.

    Product
    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
    Category
    Medical Device
    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 (Devices)·Z-1895-2024·2024-06-05

    Philips Allura Xper FD20 patient table brake may fail to engage after software update

    Philips Allura Xper FD20 X-ray systems with ADN7NT patient tables may have a pivot brake failure after software upgrade 8.1.100 is installed. This could cause unexpected table movements during use.

    Product
    Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • 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-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 (Devices)·Z-1901-2024·2024-06-05

    Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch

    Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.

    Product
    smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1924-2024·2024-06-05

    Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.

    Product
    ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1266-2024·2024-06-05

    Ganache chocolate boxes recalled for undeclared coconut allergen

    Maribel's Sweets, Inc. is recalling 2pc signature Ganache boxes nationwide due to undeclared coconut allergen. Consumers with coconut allergies should not consume this product.

    Product
    2. 2pc signature Ganache box
    Category
    Food
    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
    1 state