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.

3626–3650 of 52939

  • HighFDA (Food)·H-0551-2025·2025-09-10

    Breaded butterfly shrimp recalled over possible contamination with cesium-137

    Panko Style Breaded Butterfly Shrimp in 12 lb master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 776 cases are affected.

    Product
    Panko Style 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), Farm Raised Clean Tail. Product of Indonesia, KEEP FROZEN, Item# 1SH0318505G
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2525-2025·2025-09-10

    Flow stop cassette reservoirs recalled because medication bag welds may weaken

    Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.

    Product
    Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2506-2025·2025-09-10

    MediHoney paste tubes recalled over packaging failures breaching the sterile barrier

    MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist envir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2025·2025-09-10

    MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures

    MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2025·2025-09-10

    MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures

    MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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 (Food)·H-0566-2025·2025-09-10

    Peanut brittle recalled because peanuts and milk are missing from label

    Grandma's Old-Fashioned Peanut Brittle from The Candy Barn is recalled because peanuts and milk are missing from the contains statement. 665 packages across the firm's products are affected.

    Product
    Grandma's Old-Fashioned Peanut Brittle, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0567-2025·2025-09-10

    Pecan toffee clusters recalled because pecan is missing from label

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

    Product
    Pecan Toffee Clusters, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • 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-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
  • 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-2510-2025·2025-09-10

    MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures

    MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2025·2025-09-10

    MediHoney HCS sheet dressings recalled over packaging failures breaching sterility

    MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0559-2025·2025-09-10

    Chocolate fudge recalled because egg is missing from the contains statement

    Chocolate 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 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-2502-2025·2025-09-10

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

    Philips Azurion 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. 1,861 units are affected.

    Product
    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2025·2025-09-10

    InPen app recalled over software errors affecting insulin dose reminders

    Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

    Product
    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·PHA-09102025-01·2025-09-10

    Raw sirloin beef tips recalled due to misbranding and undeclared allergens

    The USDA FSIS issued a public health alert for Bianco & Sons raw sirloin beef tips because the product labels failed to declare common allergens—specifically sesame and wheat—posing risks to consumers with those allergies.

    Product
    Bianco Inc. — FSIS Issues Public Health Alert for Raw Sirloin Beef Tip Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0550-2025·2025-09-10

    HEB blueberry flavored yogurt pretzels recalled over undeclared wheat allergen

    HEB 8 oz Blueberry Flavored Yogurt Pretzels, lots 080226 and 080326, are recalled for an undeclared wheat allergen. The recall covers 468 cases of 12 packages each, distributed in Texas.

    Product
    Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavored Yogurt Pretzels " UPC Codes: 9787011400 " Lot Numbers: 080226, 080326 " Best By / Use By Dates: 080226 & 080326 " Package Size: 8oz " Establishment Number: 008046575
    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 (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 (Devices)·Z-2512-2025·2025-09-10

    CVS honey wound pads recalled over packaging failures breaching sterile barrier

    CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.

    Product
    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found
    Category
    Medical Device
    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