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.

8651–8675 of 53036

  • HighCPSC·24255·2024-06-06

    Biometric Firearm Safes Recalled for Unauthorized Access Risk

    SA Consumer Products is recalling Sanctuary Quick Access and Sports Afield Biometric Firearm Safes because the biometric lock can be opened by unauthorized users, posing a serious injury hazard and risk of death. No injuries have been reported.

    Product
    Sanctuary and Sports Afield Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V416000·2024-06-06

    RAM ProMaster vehicles recalled for missing side door beam and incorrect seating label

    Certain 2021-2024 RAM ProMaster vehicles lack a side door beam and have incorrect seating capacity information on the tire placard. These defects may reduce occupant protection in side-impact crashes and could result in improper vehicle loading.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E047000·2024-06-06

    Chrysler Recalls MOPAR ABS Control Modules for Software Malfunction

    Chrysler is recalling MOPAR anti-lock braking system control modules used as replacement parts in 2022 Dodge Durango and Ram 2500/3500 vehicles. A software malfunction may disable electronic stability control, increasing crash risk.

    Product
    SERVICE BRAKES, AIR:ANTILOCK:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V415000·2024-06-06

    2022 RAM 2500 Electronic Stability Control Software Defect

    Chrysler is recalling 2022 RAM 2500 and 3500 vehicles due to an ABS control module software malfunction that can disable the electronic stability control system, increasing crash risk. Dealers will provide a free software update.

    Product
    RAM — RAM, DODGE 2500, DURANGO, 3500
    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 (Drugs)·D-0510-2024·2024-06-05

    Zoledronic Acid Injection Recalled for Sterility Defect

    Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2024·2024-06-05

    Ophthalmic surgical knives recalled due to sharpness complaints

    Alcon is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel) due to increased reports of sharpness issues. The recall affects 4,930 units distributed worldwide.

    Product
    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    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-0522-2024·2024-06-05

    Bull Frog SPF 50 Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion nationwide due to the active ingredient being out of specification. Consumers with affected lots should not use the product and contact the manufacturer.

    Product
    Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
    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 (Devices)·Z-1903-2024·2024-06-05

    Stryker neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.

    Product
    Trevo ProVue, Catalog: 90184
    Category
    Medical Device
    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 (Devices)·Z-1900-2024·2024-06-05

    EsophaCap Sponge May Detach From String During Removal

    Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
    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
    1 state
  • 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-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
  • 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 (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 (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 (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 (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 (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