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.

17901–17925 of 50404

  • HighFDA (Devices)·Z-0693-2022·2022-03-09

    Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling

    ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.

    Product
    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0681-2022·2022-03-09

    Acorn stairlifts recalled due to inadequate seat structural strength

    Acorn Stairlifts Inc. is recalling multiple stairlift models because the seats may not have adequate strength to consistently support users during continued use, creating a fall hazard.

    Product
    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2022·2022-03-09

    Helix Elite Molecular Standard Fails FDA Shelf-Life Stability Testing

    Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0808-2022·2022-03-09

    Wegmans Roasted Garlic Hummus Recalled for Potential Plastic Contamination

    Wegmans brand Roasted Garlic hummus may contain blue plastic pieces. Affected units were distributed to MD, MA, NJ, NY, NC, PA, and VA.

    Product
    Wegmans brand Roasted Garlic hummus; NET WT 32 OZ (2 LB) 908 g; packaged in clear plastic container with a clear plastic snap lid; Keep Refrigerated
    Category
    Food
    Distribution
    7 states
  • HighCPSC·22096·2022-03-09

    Honda Talon 1000 ROVs recalled for engine failure and crash risk

    Honda is recalling approximately 32,000 Talon 1000 recreational off-highway vehicles from 2019-2021 because a loose intake funnel band screw can enter the engine and cause sudden failure, potentially leading to loss of control and crashes.

    Product
    Honda Talon 1000 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Statements

    BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0812-2022·2022-03-09

    Dietary supplements from Family Dollar stores recalled for rodent exposure

    Family Dollar dietary supplements were recalled due to potential rodent exposure at a distribution center. The recall affects products from six southern states purchased from January 2021 onward.

    Product
    Dietary supplements purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to vitamins, herbal and mineral supplements
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0711-2022·2022-03-09

    Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use

    Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.

    Product
    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2022·2022-03-09

    K2M Everest MI XT Outer Dilators recalled for manufacturing defect

    K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

    Product
    Everest MI XT Outer Dilator, Catalog Number 5101-90168
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2022·2022-03-09

    K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect

    K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.

    Product
    Everest MI XT Inner Dilator, Catalog Number 5101-90167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error

    BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2022·2022-03-09

    OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

    Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

    Product
    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2022·2022-03-09

    Digital Angiography System Generators May Emit Excessive X-Ray Radiation

    Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.

    Product
    Digital Angiography System Bransist safire Generator Model D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0698-2022·2022-03-09

    QC Control Panels Fail Shelf Life Stability Test at 24 Months

    Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.

    Product
    Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22093·2022-03-09

    Danby Free-Standing and Slide-In Ranges Recalled for Tip-Over Hazard

    Danby is recalling about 1,700 free-standing and slide-in electric and gas ranges because the anti-tip-over bracket may not be securely installed, creating a tip-over hazard and risk of burn injuries when heavy objects are placed on an open oven door.

    Product
    Danby brand free-standing and slide-in electric and gas ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2022·2022-03-09

    Brasseler K-WIRE surgical instruments recalled for unsealed packaging

    Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging that may compromise sterility.

    Product
    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2022·2022-03-09

    BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0803-2022·2022-03-09

    Ice Cream Mislabeled: Black Walnut Packed in Cookie Dough Container

    Signature Select Black Walnut Ice Cream was incorrectly packaged in containers labeled as Cookie Dough, which do not declare nuts as an allergen. The product lid correctly identifies the actual flavor.

    Product
    Signature Select Cookie Dough Ice Cream Vanilla Flavored ice cream with chocolate flavored chips and chunks of chocolaty chip cookie dough. Artificial Flavor added. 1.5 qt. paper container. 6 retail units per case. UPC 2113008803 Some container were filled with Black…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0804-2022·2022-03-09

    Carrot Cake Soft Bake Cookies Recalled for Undeclared Pecan Allergen

    J & M Foods is recalling Favorite Day Carrot Cake Soft Bake Cookies because pecans are listed as an ingredient but not declared in the allergen warning statement, posing a risk to consumers with pecan allergies.

    Product
    Favorite Day Carrot cake soft bake cookies Net Wt 8 oz. (227g) UPC 0 885239 25803 3 packaged in gable top carton 6 units per case
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-0810-2022·2022-03-09

    Food products from Family Dollar stores recalled due to rodent activity

    Food products from Family Dollar retail stores in six southern states are being recalled due to potential exposure to rodents and rodent activity in a distribution center. Consumers should not consume affected products.

    Product
    Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0701-2022·2022-03-09

    Helix Elite Molecular Standards recalled due to shelf life test failure

    Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
    Category
    Medical Device
    Distribution
    Distributed nationwide