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.

12351–12375 of 88183

  • 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-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 (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
    1 state
  • 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
    2 states
  • 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-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
    1 state
  • 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
  • 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
  • HighFDA (Devices)·Z-2327-2024·2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2024·2024-07-17

    Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

    Product
    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2024·2024-07-17

    Total knee prosthesis recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.

    Product
    TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2024·2024-07-17

    Medical Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling Synergetics I-Pack Injection Kits because some units may not have been properly sterilized, potentially causing post-operative wound or injection site infections.

    Product
    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0590-2024·2024-07-17

    Bupropion Extended-Release Tablets Recalled for Dissolution Failure

    Amerisource Health Services is recalling Bupropion Hydrochloride 150mg extended-release tablets nationwide due to dissolution specification failures. The tablets dissolve faster than specified limits.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1469-2024·2024-07-17

    Gluten Free Cookies Recalled for Missing Ingredient Statement on Label

    C. Krueger Finest Baked Goods is recalling 3,347 Gluten Free White Chocolate Cherry Oatmeal Cookies due to missing ingredient statements on labels, preventing consumers from identifying allergens and dietary content.

    Product
    C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-1470-2024·2024-07-17

    C. Kreuger Gluten Free Peanut Butter Cookies recalled for missing ingredient statement

    C. Krueger Finest Baked Goods is recalling C. Kreuger Gluten Free Peanut Butter Cookies due to missing ingredient statement on labels, preventing consumers from identifying allergens. The recall affects 4,538 cookies distributed across all U.S. states.

    Product
    C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-2272-2024·2024-07-17

    Mobile Operating Table Charger Defect Poses Risk of Operational Failure

    Getinge USA Sales Inc is recalling 171 ALPHAMAXX mobile operating table units due to a defective charger unit that may cause inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2326-2024·2024-07-17

    Decompression Table Model E9011 Recalled for Structural Frame Defect

    Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.

    Product
    Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2276-2024·2024-07-17

    American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals

    American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.

    Product
    MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2024·2024-07-17

    Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine

    Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.

    Product
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2024·2024-07-17

    ALPHAMAXX Operating Table Defective Charger Recalled for Operational Failure Risk

    Getinge Usa Sales Inc recalls 73 ALPHAMAXX mobile operating tables due to a defective charger unit that poses a risk of inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2279-2024·2024-07-17

    TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.

    Product
    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2024·2024-07-17

    Knee Procedure Kit Recalled for Elevated Chemical Residuals

    American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure limits.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1474-2024·2024-07-17

    Hudson Harvest Tomato Basil Sauce Recalled Due to Under-Processing

    Hudson Harvest Tomato Basil Sauce may be under-processed, creating a potential food safety risk. The recall affects 243 jars with lot #1042426 distributed in New York, Massachusetts, and Connecticut.

    Product
    Hudson Harvest Tomato Basil Sauce, 16 oz., UPC # 683720301567
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2336-2024·2024-07-17

    Ophthalmic injection kit recalled due to sterilization process verification failure

    MICROspecialties is recalling 804 units of the Synergetics I Pack Injection Kit due to inability to confirm proper sterilization, which could lead to post-operative wound infections or injection site infections.

    Product
    Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
    Category
    Medical Device
    Distribution
    1 state