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.

3651–3675 of 52939

  • HighFDA (Food)·H-0553-2025·2025-09-10

    Coconut breaded butterfly shrimp recalled over possible cesium-137 contamination

    Clean-tail Coconut Farm Raised Breaded Butterfly Shrimp in bulk master cartons, product of Indonesia, is recalled because it may be contaminated with Cesium-137. 31 cases are affected.

    Product
    Clean-tail Coconut Farm Raise Breaded Butterfly Shrimp Clean Tail (21/25 CT per pound) in bulk packaging, corrugated master cartons. Master carton case (4 x 3lb), KEEP FROZEN. Product of Indonesia, Item# 1SH0468709H
    Category
    Food
    Distribution
    13 states
  • HighNHTSA·25V589000·2025-09-10

    Volvo Recalls 2026 Models Due to Damaged Front Seat Belt Retractors

    Volvo is recalling 2026 V60, V90, XC60, and XC90 models because damaged seat belt retractors may fail to restrain occupants in a crash.

    Product
    VOLVO — VOLVO V90CCMHEV, XC60MHEV, redundant XC90MHEV, V60CCMHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0555-2025·2025-09-10

    Korean pear juice pouches recalled over missing pasteurization and sanitation records

    Evergreen Farm Korean Pear Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 610 cases distributed in three states are affected.

    Product
    Evergreen Farm Korean Pear Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, Refrigerate product after opening
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0561-2025·2025-09-10

    Chocolate mint fudge recalled because egg is not listed as allergen

    Chocolate Mint Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Mint Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0563-2025·2025-09-10

    Peanut butter fudge recalled because egg is not listed as allergen

    Peanut Butter Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Peanut Butter Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0606-2025·2025-09-10

    Compounded semaglutide 2 mL vials recalled after testing subpotent

    Semaglutide 2.5 mg/mL injection, 2 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 642 vials are affected.

    Product
    Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    Radiotherapy systems recalled over software allowing more than two daily fractions

    RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Interventional imaging systems recalled because single phase UPS may fail on power loss

    Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0560-2025·2025-09-10

    Chocolate walnut fudge recalled because walnut and egg are undeclared

    Chocolate Walnut Fudge from The Candy Barn is recalled because the specific tree nut walnut and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Walnut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0565-2025·2025-09-10

    English toffee recalled because pecans are missing from the contains statement

    English Toffee from The Candy Barn is recalled because the specific tree nut pecans is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    English Toffee, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, packed in flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0608-2025·2025-09-10

    Compounded semaglutide 0.8 mL vials recalled after testing subpotent

    Semaglutide 2.5 mg/mL injection, 0.8 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 186 vials are affected.

    Product
    Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0562-2025·2025-09-10

    Chocolate pecan fudge recalled because pecan and egg are undeclared

    Chocolate Pecan Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Pecan Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0557-2025·2025-09-10

    Jujube juice pouches recalled over missing pasteurization and sanitation records

    Evergreen Farm Jujube Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 197 cases distributed in three states are affected.

    Product
    Evergreen Farm Jujube Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, Refrigerate product after opening
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0568-2025·2025-09-10

    Lemon meringue pies recalled because Yellow No. 5 is undeclared

    Lemon Meringue Pie, 8-inch round, is recalled because FD&C Yellow No. 5 is undeclared on the label. The recall covers 136,252 cases distributed at retail across many states.

    Product
    Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; UPC: 8 85523 31811 1;Jessie's Lemon Meringue Pie Sugar Free Item Code 30811; UPC: 8 85523 30811 2; Jessie's Lemon Meringue Pie Item Code 08276; UPC: 0 41512 08275 7; First street Lemon Mering
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·H-0554-2025·2025-09-10

    Golden raisins recalled because sulfites are undeclared on the package

    Nirwana Foods Golden Raisins, 28 oz clear bags, lot 24/351-2410, are recalled because sulfites are undeclared. The product was distributed in New Jersey and New York.

    Product
    Nirwana Foods, Golden Raisin, 28 oz (794g), Net Wt. 1.75 LBS, Clear Bags, 20 bags Per Case, keep at room Temperature
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2521-2025·2025-09-10

    Tumor profiling assay recalled after incorrect result gave wrong therapy recommendation

    One MI Cancer Seek tumor mutational profiling assay is recalled because an incorrect test result was provided that indicated the incorrect drug therapy recommendation.

    Product
    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2025·2025-09-10

    CADD yellow 100 mL reservoirs recalled over weakened medication bag welds

    Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.

    Product
    Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0552-2025·2025-09-10

    Cleantail breaded butterfly shrimp recalled over possible cesium-137 contamination

    Admiral of the Fleet and Portico Seafood Classic cleantail breaded butterfly shrimp in bulk master cartons is recalled because it may be contaminated with Cesium-137. 1,200 cases are affected.

    Product
    ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), and carton case (4 x 3lb (1.36 kg), KEEP FROZEN
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·H-0564-2025·2025-09-10

    Maple nut fudge recalled because pecan and egg are not declared

    Maple Nut Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Maple Nut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·25V587000·2025-09-09

    Zero Motorcycles Recalls 2023-2024 Models Due to Wiring Defect

    Zero Motorcycles is recalling 2023-2024 DSR, DSR/X, DS, and DSRP models because improperly routed wires may break, causing a loss of drive power and increasing crash risk.

    Product
    ZERO — ZERO DS, DSR, DSR/X, DSRP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V585000·2025-09-08

    2025 Rivian R1S and R1T Recalled Due to Software Defect

    Rivian is recalling certain 2025 R1S and R1T vehicles because the Hands-Free Highway Assist software may fail to detect lead vehicles, increasing crash risk. A free over-the-air software update is available.

    Product
    RIVIAN — RIVIAN R1S, R1T
    Category
    Vehicle
    Distribution
    Distributed nationwide