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.

10426–10450 of 27089

  • HighFDA (Devices)·Z-2352-2024·2024-07-24

    Medtronic Ascenda Intrathecal Catheter design update to prevent occlusion

    Medtronic is updating the design of its Ascenda Intrathecal Catheter (Models 8780, 8781, 8784) to reduce potential tissue growth into the catheter connector that may cause occlusion. Approximately 111,762 units were distributed worldwide.

    Product
    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2024·2024-07-24

    Cochlear implant devices recalled for potential internal electronics substrate defect

    MED-EL Mi1250 SYNCHRONY 2 cochlear implants may have cracks in their internal electronics substrate that could cause device failure. Seven devices distributed to Durham, North Carolina are affected.

    Product
    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0598-2024·2024-07-24

    Oatmeal Daily Moisturizing Body Lotion Recalled Due to Mold Contamination

    Brands International Corporation is recalling Oatmeal Daily Moisturizing Body Lotion (8 fl oz) due to confirmed mold contamination. The recall affects 120,319 bottles distributed nationwide.

    Product
    Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2024·2024-07-24

    OTC Oral Care Rinse Recalled Due to Microbial Contamination

    StellaLife VEGA Oral Care Peppermint rinse is recalled nationwide due to microbial contamination with Terribacillus species. The affected product was distributed to 60 physician offices.

    Product
    STELLALIFE VEGA ORAL CARE PEPPERMINT — STELLALIFE VEGA ORAL CARE PEPPERMINT (AZADIRACHTA INDICA, CALENDULA, ECHINACEA PURPUREA, PLANTAGO MAJOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2024·2024-07-24

    Prescription Potassium Chloride Extended-Release Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers, with no reported illnesses or injuries.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1489-2024·2024-07-24

    Asli Sesame Seeds Brown Recalled for Pesticide Residue

    Sands Impex Inc. recalled Asli Sesame Seeds Brown because a product sample exceeded the FDA tolerance level for the pesticide Fenvalerate. Affected consumers should not consume the product.

    Product
    Asli Sesame Seeds Brown 14oz., UPC: 7 03440 18270 0; 20 units per wholesale case.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-1503-2024·2024-07-24

    Emergency Medical Coffee Sweet Cream Canned Beverage Recalled for Potential Under-Processing

    Snapchill, LLC is recalling Emergency Medical Coffee Sweet Cream canned beverages due to potential under-processing. The recall affects 549,146 cans with expiration dates June 16, 2024–April 16, 2025, distributed nationwide in the US and Canada.

    Product
    Coffee + Non-Dairy Creamer + Sugar-Free Sweetener Canned Beverage packaged under the following brands and sizes: 1. Emergency Medical Coffee Sweet Cream, 12 oz. UPC 8 10149-37035 9.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2252-2024·2024-07-17

    Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization

    Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1464-2024·2024-07-17

    Crecelac Infant Powdered Formula Recalled Due to Cronobacter

    Dairy Manufacturers' Crecelac Infant formula (5,376 cans distributed in Texas) is recalled due to Cronobacter spp. detected during FDA testing. Products lack required premarket evaluation for food safety and nutritional standards.

    Product
    Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1465-2024·2024-07-17

    Infant Formula Recalled for Lack of Premarket Safety Evaluation

    Farmalac 0-12 Low lactose powdered infant formula is being recalled because the manufacturer did not submit required premarket notification to the FDA. The product has not been evaluated against U.S. food safety and nutritional standards.

    Product
    Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1473-2024·2024-07-17

    Leona's Ice Cream Sandwiches Recalled for Peanut Cross-Contamination

    Leona's Strawberry Pretzel Salad ice cream sandwiches are recalled due to peanut cross-contamination. The product was distributed in Pennsylvania.

    Product
    Leona's Ice Cream , Strawberry Pretzel Salad, Individually wrapped, 6 oz. sandwich
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2315-2024·2024-07-17

    Baxter iLED 7 surgical lights recalled due to thermal burn risk

    Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.

    Product
    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2254-2024·2024-07-17

    Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates

    Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1466-2024·2024-07-17

    Queso Rico La Hacienda Queso Fresco Cheese Recalled for Listeria

    Queso Rico La Hacienda brand queso fresco cheese was found to contain Listeria monocytogenes. FDA Class I recall affects 640 pounds distributed to retail stores in Texas counties.

    Product
    Queso Rico La Hacienda brand queso fresco cheese packaged in 9 oz, 1 pound, and 2 pound plastic packages. Product labeling reads in part "***QUESO RICO LA HACIENDA***EL QUESO FRESCO FRESCO DE VERACRUZ***Lic. Permit #483709 El Queso Rico "LA HACIENDA"***5617 E. Trenton Rd., Suite
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0588-2024·2024-07-17

    OTC Sunscreen Foundation Recalled for Fungal Mold Contamination

    Suntegrity IMPECCABLE SKIN sunscreen foundation is recalled for microbial contamination with Aspergillus Sydowii mold. Consumers should discontinue use immediately.

    Product
    IMPECCABLE SKIN - IVORY — IMPECCABLE SKIN - IVORY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2251-2024·2024-07-17

    Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization

    Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2024·2024-07-17

    7-Eleven Chicken Salad Sandwich Recalled for Undeclared Milk Allergen

    Taylor Farms Northwest recalled 7-Eleven Simply Chicken Salad Sandwiches for containing undeclared milk. The Class I recall affects 319 units distributed in Oregon and Washington.

    Product
    7-Eleven Simply Chicken Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.6oz (187g)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1472-2024·2024-07-17

    Arepas La Mejor Arepa de Chocolo Recalled for Undeclared Milk Allergen

    Villa Nueva Interservices is recalling Arepas La Mejor Arepa de Chocolo due to undeclared milk allergen. Consumers with milk allergies are at risk.

    Product
    Arepas La Mejor, Arepa de Chocolo (Chocolate Sweet Corn Pancakes), NET WT. 25 Oz., 5 units per package, KEEP REFRIGERATED
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2314-2024·2024-07-17

    Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries

    Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.

    Product
    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2253-2024·2024-07-17

    BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure

    FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1463-2024·2024-07-17

    Powdered infant formula recalled for missing safety evaluation

    Farmalac powdered infant formula was recalled because the manufacturer failed to submit required premarket notification to the FDA. The product was never evaluated for safety or nutritional standards.

    Product
    Farmalac powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2313-2024·2024-07-17

    Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk

    Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.

    Product
    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1468-2024·2024-07-17

    7-Eleven Simply Egg Salad Sandwich recalled due to undeclared milk allergen

    Taylor Farms Northwest LLC has voluntarily recalled 7-Eleven Simply Egg Salad Sandwich (6.8 oz) due to undeclared milk, affecting products distributed in Oregon and Washington.

    Product
    7-Eleven Simply Egg Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.8oz (193g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2024·2024-07-17

    Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue

    American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.

    Product
    FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
    Category
    Medical Device
    Distribution
    Distributed nationwide