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.

15801–15825 of 27263

  • SevereFDA (Food)·F-1257-2023·2023-07-26

    Frozen Mango Chunks Recalled for Potential Listeria Contamination

    SunOpta's frozen mango chunks sold nationwide under Great Value and Good & Gather brands are recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Mango Chunks packaged under the following brand names and sizes. 1. Great Value. Net Wt 16 oz (1 lb) 454g UPC 0 78742-02550 6. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716 2. Good & Gather. Net Wt 12 oz (340 g). UPC 0 85239-04786 6. Keep Frozen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1259-2023·2023-07-26

    Good & Gather Frozen Blueberries Recalled for Potential Listeria Contamination

    Target's Good & Gather frozen blueberries are being recalled nationwide due to potential Listeria monocytogenes contamination affecting approximately 3,894 cases.

    Product
    Good & Gather Blueberries. Net Wt 48 oz (3lb) 1.36kg UPC 0 85239-04813 9. Keep Frozen. Distributed by Target Corporation Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2023·2023-07-26

    Impella LD cardiac pump recalled for impeller damage and embolization risk

    Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.

    Product
    Impella LD intravascular micro axial blood pump, Product Number 005082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2013-2023·2023-07-26

    Olympus Bronchoscope Recall: Risk of Combustion During Laser Procedures

    Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.

    Product
    Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1275-2023·2023-07-26

    Townsend Farms Frozen Mixed Berries Recalled for Listeria Risk

    Townsend Farms' Private Selection frozen blueberries, strawberries, and mangoes are recalled due to potential Listeria monocytogenes contamination. Approximately 34,944 bags were distributed across 16 U.S. states.

    Product
    Private Selection 48oz Blueberries, Strawberries & Mangoes, frozen product, 8/48 oz bags per case. UPC 0 11110 89623 0. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2114-2023·2023-07-26

    Abiomed Impella 5.5 pump recalled due to impeller blade damage risk

    Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.

    Product
    Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1269-2023·2023-07-26

    Frozen Mixed Fruit Blend Recalled for Potential Listeria Contamination

    SunOpta's Good & Gather brand frozen mixed fruit blend is recalled nationwide due to potential Listeria monocytogenes contamination. Affected consumers should not consume this product and should return it to the retailer.

    Product
    Good & Gather Mixed Fruit Blend Pineapple Chunks, Sliced Strawberries, Mango Chunks & Sliced Peaches. Net Wt 48 oz (3lb) 1.36kg. UPC 0 85239-04821 4. Keep Frozen. Dist. By Target Corp, Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2023·2023-07-26

    Impella 2.5 blood pump recalled due to impeller blade damage risk

    Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.

    Product
    Impella 2.5 intravascular micro axial blood pump, Product Number 005042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2150-2023·2023-07-26

    Intra-Aortic Balloon Pump may fail to charge batteries, interrupting therapy

    The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1256-2023·2023-07-26

    Frozen Pineapple Chunks Recalled Due to Listeria Contamination Risk

    SunOpta Grains and Foods Inc. is recalling nationwide frozen pineapple chunks sold under the 365 Whole Foods Market and Bulk Organic brands due to potential Listeria monocytogenes contamination.

    Product
    Pineapple Chunks packaged under the following brand names and sizes. 1. 365 Whole Foods Market, Net Wt 16 oz (1 lb) 454g UPC 0 99482-40854 1. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703. 2. 365 Whole Foods Market, Net Wt 10 oz (284g) UPC 0 994
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1255-2023·2023-07-26

    Frozen Pineapple Products Recalled Due to Listeria Contamination

    Scenic Fruit Company recalls Cadia and Trader Joe's frozen pineapple products due to potential Listeria monocytogenes contamination. Consumers should not consume the recalled items.

    Product
    Cadia - Organic Pineapple Frozen Fruit, packaged in stand-up pouch, net wt. 10oz. Each case consists of 12 bags. Product of Mexico. UPC on Retail Bag: 815369014540 UPC on Case: 10815369014547 Cadia FS - Organic Frozen Pineapple Chunks, net wt. 5lbs. Each case consists of 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1263-2023·2023-07-26

    Great Value Mixed Fruit Recalled for Potential Listeria Contamination

    Walmart's Great Value Mixed Fruit is recalled for potential Listeria monocytogenes contamination. The FDA issued a Class I recall affecting approximately 70,360 cases distributed nationwide.

    Product
    Great Value Mixed Fruit. Pineppple, Strawberries, Peaches and Mango. Net Wt 16 oz (1 lb) 454g, UPC 0 78742-02551 3. Keep Frozen. Distributed by: Walmart Inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1273-2023·2023-07-26

    Frozen Tropical Mango Chunks Recalled for Listeria Risk

    Townsend Farms Inc is recalling Private Selection frozen tropical mango chunks due to potential Listeria monocytogenes contamination. The product was distributed across 16 U.S. states.

    Product
    Private Selection 48oz Tropical Mango Chunks, frozen product, 8/48 oz bags per case. UPC 0 11110 84663 1. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1270-2023·2023-07-26

    Seasons Choice frozen fruit blend recalled for potential Listeria contamination

    Aldi's Seasons Choice frozen tropical fruit blend is being recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Seasons Choice Tropical Blend, Pineapple, Mango, Strawberries & Papaya. Net Wt 32 oz (2lb) 907g. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1258-2023·2023-07-26

    365 Whole Foods Market Organic Strawberries Recalled for Potential Listeria Contamination

    SunOpta Grains and Foods Inc. is recalling 365 Whole Foods Market Organic Whole Strawberries due to potential Listeria monocytogenes contamination. The frozen strawberries were distributed nationwide.

    Product
    365 Whole Foods Market Organic Whole Strawberries. Net Wt 32 oz (2 lb) 907 g, UPC 0 99482-45713 6. Keep Frozen until ready to use. Distributed By: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2012-2023·2023-07-26

    Olympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures

    Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.

    Product
    Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1279-2023·2023-07-26

    Fry Daddy's Ranch Party Mix recalled for undeclared walnut allergen

    Fry Daddy's Brand is recalling Fry Daddy's Ranch Party Mix (3.75oz and 12oz bags) distributed in Michigan due to undeclared walnut content. Approximately 4,505 units with sell-by dates from June 1 through December 31, 2023 are affected.

    Product
    Fry Daddy's Ranch Party Mix 3.75oz and 12oz bags UPCs 86007991530 and 850047648037. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1252-2023·2023-07-26

    Food product recall: Undeclared milk in Phillips Butterscotch Cone Coating

    Lyons Magnus LLC recalls Phillips Butterscotch Cone Coating due to undeclared milk, which was not listed on the label. Consumers with milk allergies face a health risk.

    Product
    Phillips Butterscotch Cone Coating; packaged in 96fl oz metal cans, 6 cans per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1278-2023·2023-07-26

    Fry Daddy's Cheddar Party Mix Recalled Due to Undeclared Walnut

    Fry Daddy's Cheddar Party Mix is being recalled because it contains undeclared walnut, which poses a risk to consumers with walnut allergies. The recall affects approximately 6,613 retail units sold in Michigan.

    Product
    Fry Daddy's Cheddar Party Mix 3.75oz and 12oz bags UPCs 860007991523 and 850047648020. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2211-2023·2023-07-26

    Blood Glucose Meters Display Glucose Levels in Wrong Unit of Measure

    Ascensia is recalling blood glucose meters that display measurements in mmol/L instead of mg/dL. If not caught, the incorrect unit may cause patients to misread their glucose levels with serious health consequences.

    Product
    Contour¿ next GEN Blood Glucose Monitoring System
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2147-2023·2023-07-26

    Infant Heel Warmer Recalled Due to Burst and Leaking

    Cardinal Health is recalling 44,500 NovaPlus Infant Heel Warmers from lot V2S056 due to reports of bursting and leaking. Units were distributed nationwide.

    Product
    NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate barrier at seams

    Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling 2739 units of probe cover kits used in diagnostic ultrasound and catheter insertion procedures due to inadequate barriers at seams that could compromise sterility.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling probe cover kits containing sterile ultrasound gel due to inadequate barriers at the seams, which may compromise sterility during diagnostic ultrasound procedures. The recall affects 2,590 units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION
    Category
    Medical Device
    Distribution
    Distributed nationwide