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.

20101–20125 of 88183

  • CriticalFDA (Drugs)·D-0455-2023·2023-03-15

    Hand Sanitizer Recalled for Methanol and Acetaldehyde Contamination

    Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.

    Product
    Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1148-2023·2023-03-15

    Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

    The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

    Product
    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0417-2023·2023-03-15

    Chukar Cherries Cherry Bombs Recalled Nationwide for Undeclared Hazelnuts

    Chukar Cherry Company is recalling Cherry Bombs Bits 'n Pieces chocolate candy nationwide due to undeclared hazelnuts, a food allergen.

    Product
    Chukar Cherries Cherry Bombs Bits 'n Pieces, item #21508, net wt. 12 oz. (340g). UPC 0 11261 21508 9. Product is packaged in clear plastic film pouch. INGREDIENTS: Milk, Bittersweet, Semisweet, and White Chocolate (Sugar, Unsweetened Chocolate processed with potassium…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1145-2023·2023-03-15

    Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0411-2023·2023-03-15

    JSJ ZSR Cake recalled for undeclared egg allergen

    Titans Global Inc. is recalling JSJ ZSR Cake due to undeclared egg on the label. The recall affects 12,432 units distributed to five retail locations in California.

    Product
    JSJ ZSR Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0412-2023·2023-03-15

    JSJ DMC Leaf Cake recalled due to undeclared egg allergen

    JSJ DMC Leaf Cake (3.35 oz, produced 2022/11/08) has been recalled because egg is present but not declared on the label. The recall affects 12,432 units distributed to 5 retail locations in California.

    Product
    JSJ DMC Leaf Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0410-2023·2023-03-15

    JSJ Chocolate Cake Recalled for Undeclared Egg Allergen

    Titans Global Inc. is recalling JSJ Chocolate Cake due to undeclared egg not listed on the label. The recall affects 12,432 units distributed to five retail locations in California.

    Product
    JSJ Chocolate Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1147-2023·2023-03-15

    Cardiosave Hybrid IABP Recalled for Risk of Unexpected Shutdown

    The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.

    Product
    Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53*…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2023·2023-03-15

    Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination

    Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.

    Product
    Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1146-2023·2023-03-15

    Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0433-2023·2023-03-15

    Eye Drop Recall: Brimonidine Tartrate Due to Cracked Bottle Caps

    Apotex Corp. is recalling Brimonidine Tartrate eye drops (67,056 bottles nationwide) because cracks in bottle caps may compromise sterility and expose patients to contamination.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2023·2023-03-15

    Sprint 200 Wheeled Stretcher Siderail Labeling Update to Prevent Falls

    FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.

    Product
    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1220-2023·2023-03-15

    CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions

    CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0416-2023·2023-03-15

    Shirakiku Shichimi Togarashi Spice Recalled for Undeclared Sesame

    Shirakiku Shichimi Togarashi spice (Lot 12262023) is recalled because it contains undeclared sesame due to potential product mix-up. The 2,617 packages were distributed nationwide and internationally.

    Product
    SPICE SHICHIMI TOGARASHI 300g UPC: 074410341213 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2023·2023-03-15

    CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers

    FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0439-2023·2023-03-15

    NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect

    Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.

    Product
    NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2023·2023-03-15

    Radiation Therapy System Software Issue May Cause Unexpected Dose

    Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.

    Product
    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1214-2023·2023-03-15

    Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue

    Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.

    Product
    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2023·2023-03-15

    COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

    DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

    Product
    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2023·2023-03-15

    Blood Sample Collection Kits Shipped With Incorrect Identification Labels

    LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.

    Product
    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0418-2023·2023-03-15

    Given Imaging SmartBar Cereal Bar Recalled for Potential Tobacco Beetle Contamination

    Given Imaging Ltd. is recalling SmartBar Cereal Bars because they may be contaminated with tobacco beetles. Consumers should not consume the affected product.

    Product
    Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert…
    Category
    Food
    Distribution
    38 states
  • HighFDA (Devices)·Z-1216-2023·2023-03-15

    LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying

    Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.

    Product
    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0438-2023·2023-03-15

    NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation

    Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.

    Product
    NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2023·2023-03-15

    CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices

    St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.

    Product
    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33…
    Category
    Medical Device
    Distribution
    Distributed nationwide