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.

11326–11350 of 22152

  • HighNHTSA·23V358000·2024-06-05

    2021-2023 Ford Bronco Seat Belt Latch Accessibility Recall

    Ford is recalling certain 2021-2023 Bronco vehicles because first-row seat belt latch plates may be difficult to access, potentially preventing occupants from wearing their seat belts and increasing crash injury risk.

    Product
    FORD — 2022 FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2024·2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in 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 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2024·2024-06-05

    Neurovascular devices recalled due to inadequate endotoxin testing

    Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.

    Product
    DAC 044 115cm, Catalog: 90760
    Category
    Medical Device
    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
  • HighNHTSA·22V387000·2024-06-05

    2021-2022 Escape Travel Trailers Recalled for Cracked LP Gas Fittings

    Escape Trailer is recalling 2021-2022 Escape travel trailers (models 17, 19, 21, and 5.0TA) due to cracked quick disconnect fittings in the LP gas system that may cause a gas leak and fire hazard.

    Product
    ESCAPE — 2021 ESCAPE ESCAPE 21
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-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-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-1914-2024·2024-06-05

    Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements

    Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper 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.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V352000·2024-06-05

    Jeep Grand Cherokee Steering Column Intermediate Shaft Defect Recall

    Certain 2021–2023 Jeep Grand Cherokee models have an incorrectly assembled steering column intermediate shaft that may disconnect and cause loss of steering control, increasing crash risk. Chrysler is offering free inspection and replacement.

    Product
    JEEP — 2021 JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2024·2024-06-05

    ALOE GATOR SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
    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-1929-2024·2024-06-05

    BD Pyxis MedStation ES 7-Drawer Auxiliary Tower Recalled for Fire Risk

    CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V316000·2024-06-05

    2024 Mercedes-Benz eSprinter Brake Control Software Defect Recall

    Daimler Vans USA is recalling certain 2024 Mercedes-Benz eSprinter vehicles due to a software error in the electronic stability program that may extend braking distance and increase crash risk. Dealers will provide a free software update.

    Product
    MERCEDES-BENZ — 2024 MERCEDES-BENZ ESPRINTER
    Category
    Vehicle
    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 (Drugs)·D-0513-2024·2024-06-05

    Intraocular Injection Recalled for Sterility Assurance Failure

    Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.

    Product
    Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
    Category
    Drug
    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 (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
  • 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 (Devices)·Z-1897-2024·2024-06-05

    Philips Allura Xper FD20 Software Update Disables Pivot Brake on Patient Table

    A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
    Category
    Medical Device
    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-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • HighNHTSA·23V275000·2024-06-04

    2023 Mazda CX-50 and CX-30 Brake Control Unit Defect Recall

    Mazda is recalling certain 2022-2023 CX-30 and 2023 CX-50 vehicles because the anti-lock brake system hydraulic control unit may be damaged, reducing braking ability and increasing crash risk.

    Product
    MAZDA — 2023 MAZDA CX-50
    Category
    Vehicle
    Distribution
    Distributed nationwide