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.

22201–22225 of 88183

  • SevereFDA (Devices)·Z-1763-2022·2022-10-05

    TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide

    FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.

    Product
    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1791-2022·2022-10-05

    Chocolate to Die For Premium Ice Cream recalled for undeclared peanuts

    Belfonte Ice Cream's Chocolate to Die For Premium Ice Cream may contain undeclared peanuts. Affected products were sold at Hy-Vee, Cash Saver, Harps, Price Mart, and Heartland in Kansas City, Tulsa, Columbia, and Springfield areas.

    Product
    1.5 quarts (1.41 L) Chocolate to Die For Premium Ice Cream UPC: 83057 17049 Plant Code 29-050
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1798-2022·2022-10-05

    Aged Raw Milk Cheese Recalled for Listeria Contamination Risk

    Keswick Creamery recalls Calverley aged raw milk cheese due to potential Listeria monocytogenes contamination affecting products distributed to farm stores and farmers markets in DC, MD, VA, and PA.

    Product
    Aged raw milk cheese "Calverley" 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1801-2022·2022-10-05

    Pasteurized Havarti cheese recalled for potential Listeria contamination

    Keswick Creamery is recalling Havarti cheese due to potential Listeria monocytogenes contamination. All products manufactured by the firm may be affected.

    Product
    Pasteurized milk cheese "Havarti" 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1799-2022·2022-10-05

    Aged Raw Milk Feta Cheese Recalled for Listeria Risk

    Keswick Creamery is recalling aged raw milk feta cheese due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in DC, Maryland, Virginia, and Pennsylvania.

    Product
    Aged raw milk cheese "Feta" in 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1795-2022·2022-10-05

    Aged raw milk cheese recalled for potential Listeria monocytogenes contamination

    Keswick Creamery is recalling Ploughman Cider Wash Tomme aged raw milk cheese (batch 47) due to potential Listeria monocytogenes contamination. The product was distributed to farm stores and farmers markets in Washington DC, MD, VA, and PA.

    Product
    Aged raw milk cheese "Ploughman Cider Wash Tomme" batch 47 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1804-2022·2022-10-05

    Vermeer Cheese Products Recalled for Potential Listeria Contamination

    Keswick Creamery is recalling Vermeer Cheese due to potential Listeria monocytogenes contamination. Products were distributed to farm stores and farmers markets in Washington DC, Maryland, Virginia, and Pennsylvania.

    Product
    Vermeer Cheese in 4 oz to 12 oz packages
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1793-2022·2022-10-05

    Yellow Squash from Southeast Processing Recalled for Listeria monocytogenes

    Southeast Processing Ltd is recalling yellow squash sold in multiple forms due to positive detection of Listeria monocytogenes in product samples. The affected product was distributed to Georgia and South Carolina.

    Product
    Yellow Squash sold as Bulk, Diced, Half Moon Sliced, Julienne and Planks (Product codes 168-173)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1805-2022·2022-10-05

    Alexia Organic Seasoned Hashed Browns recalled for potential Listeria contamination

    Lamb Weston Sales is recalling Alexia Organic Seasoned Hashed Browns Yukon Select Potatoes due to potential Listeria monocytogenes contamination. The frozen product was distributed nationwide and internationally.

    Product
    Item AX058, Alexia Organic Seasoned Hashed Browns Yukon Select Potatoes, 16 oz. bag, 12/16 oz. bags per case. Product is frozen and it's not ready to eat and labeled with cooking instructions. Produced by Lamb Weston, Kennewick, WA. UPC 8 34183 00303 5. Product contains…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1790-2022·2022-10-05

    Alida's Samoon Pita Bread recalled for undeclared soy allergen

    Alida's Bakery is recalling Alida's Samoon Pita Bread because canola oil used in production contained undeclared soy lecithin. The recall affects 19 bags distributed in Washington state.

    Product
    Alida's Samoon Pita Bread, 4 pieces per package, net wt. 21 oz. UPC 8 60004 65933 4. Product contains ingredients: While Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, Salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1855-2022·2022-10-05

    Medline ClearPro Suction Catheter Connector May Separate During Use

    Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 units distributed nationwide and internationally.

    Product
    MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2022·2022-10-05

    Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal

    Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.

    Product
    Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1794-2022·2022-10-05

    Organic GreenWise Animal Crackers recalled for undeclared tree nut allergen

    Toufayan Bakery is recalling Organic GreenWise Animal Crackers due to undeclared coconut (tree nut) on the label. Consumers with tree nut allergies should not consume this product.

    Product
    Organic GreenWise Animal Crackers, NET WT 8 OZ (227 g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1840-2022·2022-10-05

    Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2022·2022-10-05

    Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

    Product
    Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2022·2022-10-05

    Cook Medical Wire Guide Devices Recalled for Packaging Breach

    Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.

    Product
    Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2022·2022-10-05

    t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

    Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-1788-2022·2022-10-05

    Alida's Saoka Pita Bread recalled for undeclared soy allergen

    Alida's Saoka Pita Bread contains undeclared soy lecithin from cooking oil, posing a risk to people with soy allergies. The product was distributed in Washington state.

    Product
    Alida's Saoka Pita Bread, 5 pieces per package. Net Wt. 16.25 oz. UPC 8 60004 65930 3. Product contains ingredients: White Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, Salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1792-2022·2022-10-05

    A&W Root Beer Zero Sugar Recalled for Undeclared Sugar Content

    A&W Root Beer Zero Sugar in 20oz bottles is being recalled because it contains full sugar but is labeled as sugar-free. The affected product has lot number 071892 and was distributed in DC, MD, PA, and VA.

    Product
    "A&W Root Beer Zero Sugar" packaged in 20oz PET bottles. UPC: 00-0-78000-05340-1
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1785-2022·2022-10-05

    BD Pyxis MedBank Cabinet Software Update Prevents Drawer Access

    A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2022·2022-10-05

    Barco Medical Network Adapter Recalled for Installation Issues

    Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.

    Product
    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2022·2022-10-05

    Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility

    Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.

    Product
    Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2022·2022-10-05

    Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall

    CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-1548-2022·2022-10-05

    Akorn Rifampin Capsules Recalled for Impurity Specification Failure

    Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.

    Product
    Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
    Category
    Drug
    Distribution
    Distributed nationwide