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.

14376–14400 of 22168

  • HighFDA (Food)·F-1434-2023·2023-08-23

    Benton's Snack Packs Recalled for Undeclared Peanut Allergen

    Benton's 100 Calorie Snack Packs are recalled because they contain undeclared peanut, a major allergen. Consumers with peanut allergies may experience severe reactions if they consume this product.

    Product
    Benton's 100 Calorie Snack Packs Baked Chocolate Wafer Snacks 6-0.81 OZ (23g) Packs Net Wt. 4.86 oz UPC: 4 099100 040416 Packaged in a paper carton, 16 cartons per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2405-2023·2023-08-23

    Hip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm

    Conformis hip screws measuring 30mm have been mislabeled as 25mm, creating risk of incorrect surgical implantation. The recall affects 25 units distributed across nine states.

    Product
    CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1427-2023·2023-08-23

    Romaine Lettuce Recalled Due to Deer Feces Contamination

    G.O. Corporation is recalling Romaine Lettuce 80/20 GB due to potential contamination with deer feces. The affected products were distributed to Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Lettuce Romaine 80/20 GB, packaged in the following sizes and configurations: 1. Produce Code 448007, 2-5 lb. bags per shipping case, 2. Produce Code 448007, 4-5 lb. bags per shipping case, 3. Produce Code 448110, 4-5 lb. bags per shipping case.
    Category
    Food
    Distribution
    4 states
  • HighCPSC·23782·2023-08-17

    Midwest Lubricants Sodium Hydroxide Recalled for Unsafe Packaging

    Midwest Lubricants is recalling about 3,000 units of Sodium Hydroxide (Caustic Soda Beads) because the packaging is not child-resistant and the label lacks required hazard information. The product poses a risk of chemical burns and eye irritation.

    Product
    Midwest Lubricants Sodium Hydroxide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23265·2023-08-17

    Simplay3 Toddler Towers Recalled Due to Fall and Injury Hazards

    Simplay3 Toddler Towers can tip over during use, posing fall and injury hazards to young children. The manufacturer has received 16 reports of tipping, including 10 reports of injuries.

    Product
    Simplay3 Toddler Towers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1376-2023·2023-08-16

    Bellingham Pasta Co Recalls Semolina Linguine for Undeclared Wheat

    Bellingham Pasta Co recalls Semolina Roasted Red Pepper Linguine (14oz) due to undeclared wheat allergen. The product was distributed in Washington state.

    Product
    Semolina Roasted Red Pepper Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Egg, Red Sweet Peppers, Water, Sea Salt, Citric Acid, Whole Grain Brown Rice. Ke
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1388-2023·2023-08-16

    Sweet Alchemy Strawberry ice cream recalled for undeclared allergens

    Sweet Alchemy Strawberry ice cream in pints fails to declare Egg and Milk allergens on labels. Fifteen pints distributed in Washington are affected.

    Product
    Sweet Alchemy Strawberry ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2355-2023·2023-08-16

    LINK MP Hip Stem Trial Instruments difficult to remove after implantation

    The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force

    LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2023·2023-08-16

    LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty

    Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2023·2023-08-16

    Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update

    Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.

    Product
    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2023·2023-08-16

    Ellacor System recalled for bearing adhesive defect risk

    The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.

    Product
    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1397-2023·2023-08-16

    Sweet Alchemy Vegan Raspberry Chip Ice Cream Recalled for Missing Allergen Declarations

    Sweet Alchemy Vegan Raspberry Chip ice cream sold in Washington State lacks allergen declarations for Coconut and Soy on its labels. Allergic consumers should not consume this product.

    Product
    Sweet Alchemy Vegan Raspberry Chip ice cream, coconut-based product, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2366-2023·2023-08-16

    Medline Total Hip Kit Recalled for Expired Prep Solution

    Medline is recalling the Total Hip Kit (REF DYNJ903275S) because the included prep solution expires before the kit itself expires. Sixteen kits with lot code 23CDC733 were distributed nationwide.

    Product
    Total Hip Kit, REF DYNJ903275S; surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2023·2023-08-16

    Hip implant trial stem: increased removal force may extend surgery

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2023·2023-08-16

    Sweet Alchemy Blackberry Crumble ice cream recalled for undeclared allergens

    Sweet Alchemy Blackberry Crumble ice cream pints lack required ingredient and allergen labeling, specifically failing to declare milk, egg, and wheat allergens.

    Product
    Sweet Alchemy Blackberry Crumble ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2357-2023·2023-08-16

    VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells

    ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2023·2023-08-16

    Semolina linguine pasta recalled for undeclared wheat allergen

    Bellingham Pasta Co is recalling semolina linguine due to missing wheat allergen declaration on the label. Consumers with wheat allergies may be at risk.

    Product
    Semolina Linguine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8 98975 00204 0.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1387-2023·2023-08-16

    Sweet Alchemy Lemon Custard Ice Cream Recalled Due to Missing Allergen Labeling

    Sweet Alchemy Ice Creamery is recalling Lemon Custard ice cream cups because labels fail to declare ingredients, including the allergens Egg and Milk.

    Product
    Sweet Alchemy Lemon Custard ice cream, distributed in cups. Label declares company name, flavor name, but does not declare ingredients and allergens.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2358-2023·2023-08-16

    FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives

    Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Calibrators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2023·2023-08-16

    Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

    Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

    Product
    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1375-2023·2023-08-16

    Bellingham Pasta Semolina Spinach Fettuccine Recalled for Undeclared Wheat Allergen

    Bellingham Pasta Co. is recalling 38 packages of Semolina Spinach Fettuccine sold in Washington because the label does not declare wheat, a major allergen present in the product.

    Product
    Semolina Spinach Fettuccine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, Organic Spinach Powder, dusted with Brown Rice Flour. Keep Refrigerated. UPC 8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1398-2023·2023-08-16

    FDA Recalls Romaine Lettuce Due to Potential Deer Fecal Contamination

    C&E Farms is recalling 8,010 mini-bins of bulk romaine lettuce that may be contaminated with deer feces. The affected lettuce was distributed to retailers in seven U.S. states.

    Product
    Romaine lettuce packed in bulk 45-lb mini-bins
    Category
    Food
    Distribution
    7 states