The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

1751–1775 of 26545

  • HighFDA (Food)·H-0464-2026·2026-02-11

    Spicely Organic Celery Salt Recalled for Mislabeled Sodium Content

    Spicely Organic celery salt labeled 'NO SALT' contains salt as a primary ingredient. Consumers on sodium-restricted diets should not consume this product.

    Product
    spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2.4oz (68g) Ingredients: Salt, *Celery Seeds *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007605
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-0305-2026·2026-02-11

    Prescription Drug Trazodone Recalled Due to Foreign Tablet Contamination

    Granules Pharmaceuticals Inc. is recalling Trazodone Hydrochloride 50 mg tablets due to the presence of foreign tablets or capsules in some bottles. Patients should stop use and contact their pharmacy.

    Product
    TRAZODONE HYDROCHLORIDE — TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2026·2026-02-11

    PRISMAFLEX TPE2000 dialyzer sets recalled for chamber dislodgement

    VANTIVE US HEALTHCARE is recalling 13,760 PRISMAFLEX TPE2000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.

    Product
    PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0472-2026·2026-02-11

    Sea Moss Gel Superfood Recalled Due to Botulism Contamination Risk

    Diva Fam Inc is recalling Sea Moss Gel Superfood nationwide due to potential Clostridium botulinum contamination. No illnesses have been reported.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0462-2026·2026-02-11

    M&Ms Candies Recalled for Undeclared Milk, Soy, and Peanut Allergens

    Beacon Promotions Inc is recalling repackaged M&Ms candies (Item BB458BG) because they contain undeclared milk, soy, and peanut allergens. Consumers with allergies to these ingredients are at risk.

    Product
    Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Pu
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·H-0478-2026·2026-02-11

    Sea Moss Gel Superfood recalled due to potential botulinum contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood products nationwide due to potential Clostridium botulinum contamination. Consumers should discard the product and stop using it.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0467-2026·2026-02-11

    Sea Moss Gel Superfood Recalled Due to Potential Botulinum Contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood nationwide due to potential Clostridium botulinum contamination. The product was distributed through retail and online channels.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0483-2026·2026-02-11

    Imu-Tek Immuno-5 Colostrum Powder recalled due to undeclared milk allergen

    Imu-Tek Immuno-5 Colostrum Powder 7 oz (Lot #216) is being recalled due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 00033 5 Firm name on label: Imu-Tek, 3541 East Vine Drive, Fort Collins,
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·H-0477-2026·2026-02-11

    Sea Moss Gel Superfood Recalled for Potential Botulism Contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood due to potential Clostridium botulinum contamination. The product is distributed nationwide; consumers should not consume affected units.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0480-2026·2026-02-11

    Sea Moss Gel Superfood Recalled Due to Potential Botulinum Contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood due to potential Clostridium botulinum contamination. Consumers should not consume the affected product and should return it to the place of purchase.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0468-2026·2026-02-11

    Sea Moss Gel Superfood recalled for potential botulinum contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood Pineapple nationwide due to potential Clostridium botulinum contamination. Consumers should not consume the product.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0484-2026·2026-02-11

    Willy Pete's Chocolates Almond Despair Dark Chocolate Recalled for Undeclared Almonds

    Willy Pete's Chocolates Almond Despair is recalled because almonds are not declared in the ingredient statement, posing a risk to consumers with tree nut allergies. The product was distributed in Massachusetts, South Carolina, and Connecticut.

    Product
    Willy Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) &
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0475-2026·2026-02-11

    Sea Moss Gel Superfood Recalled for Potential Botulism Contamination

    Diva Fam Inc is recalling cherry-flavored sea moss gel due to potential Clostridium botulinum contamination. The product was distributed nationwide through retail and online channels.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0471-2026·2026-02-11

    Sea Moss Gel Superfood Recalled for Potential Botulism Contamination

    Diva Fam Inc is recalling Sea Moss Gel Superfood (16 FL OZ jars) due to potential Clostridium botulinum contamination. The product is distributed nationwide.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0447-2026·2026-02-11

    BarbaCuban Cubama White Truffle Sauce Recalled for Undeclared Quinine

    Prima Foods International voluntarily recalled BarbaCuban Cubama White Truffle Sauce because the product contains undeclared quinine. The recall affects 12,214 bottles distributed in Florida.

    Product
    BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1268-2026·2026-02-11

    Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation

    Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2026·2026-02-11

    FDA Recalls Single Use Sphincterotome Due to Deformation Risk

    Olympus is recalling Single Use 3-Lumen Sphincterotome V instruments (Model KD-V411M-3020) because some devices may not have undergone proper thermoforming, causing potential deformation and performance loss. The recall affects 650 units.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2026·2026-02-11

    Single Use Sphincterotomes recalled for potential deformation and performance loss

    Olympus Corporation is recalling approximately 2,344 Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects that could cause deformation and loss of surgical performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2026·2026-02-11

    Surgical Backflush Needles Recalled for Compromised Sterile Barrier

    Vortex Surgical is recalling surgical backflush needles due to voids in Tyvek pouch seals that compromise the sterile barrier. The defect could allow bioburden contamination leading to infection risk.

    Product
    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2026·2026-02-11

    MiniMed 780G Insulin Pump Software Error May Suspend Delivery

    A software timing issue in MiniMed 780G insulin pumps (software version 6.60) may trigger pump errors that suspend insulin delivery. 577 units are affected, distributed in the US and Israel.

    Product
    MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1276-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance

    Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2026·2026-02-11

    Dialyzer deaeration chamber may dislodge from control unit

    VANTIVE US HEALTHCARE is recalling 115,112 PRISMAFLEX HF1000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.

    Product
    PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2026·2026-02-11

    Surgical screws recalled due to labeling error and size mismatch

    A lot of Tornier surgical screws is labeled as 5.0mm x 18mm but actually measures 5.0mm x 14mm. If undetected during surgery, the incorrect screw could increase the risk of mechanical failure and require revision surgery.

    Product
    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2026·2026-02-11

    Olympus Sphincterotome Recall: Risk of Device Deformation and Performance Loss

    Olympus is recalling sphincterotomes that did not undergo proper thermoforming, which could cause device deformation and loss of performance. The 5,089 affected units were distributed throughout the US and internationally.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo Urine Test Strips Recalled for Inaccurate Diagnostic Results

    Vivoo Sodium, Vitamin C, and Hydration test strips distributed without FDA clearance may provide inaccurate diagnostic results, potentially leading to inappropriate medical intervention.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide