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.

15851–15875 of 27263

  • HighFDA (Devices)·Z-2157-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect

    Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2023·2023-07-26

    Medline probe cover kits recalled for inadequate seam barrier protection

    Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL
    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-2198-2023·2023-07-26

    Medline Probe Cover Kits recalled due to inadequate seam barriers

    Medline Probe Cover Kits may have inadequate seam barriers that could allow contamination during diagnostic ultrasound procedures. Approximately 575 units have been distributed worldwide since December 2017.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2023·2023-07-26

    Medline ultrasound probe cover kits recalled for inadequate seam barriers

    Medline Industries has recalled 1,505,262 Probe Cover Kits used in diagnostic ultrasound procedures due to an inadequate barrier at the seams. The recall affects units distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0933-2023·2023-07-26

    Norepinephrine injectable recalled due to lack of sterility assurance

    SterRx is recalling 92,148 bags of norepinephrine injectable due to lack of assurance of sterility. The prescription medication was distributed nationwide.

    Product
    Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1274-2023·2023-07-26

    Frozen Fruit Smoothie Blend Recalled Due to Listeria Risk

    Townsend Farms is recalling Private Selection frozen strawberry, mango, and pineapple smoothie blend due to potential Listeria monocytogenes contamination. The product was distributed across 16 states.

    Product
    Private Selection 16oz Strawberry, Mango & Pineapple Blend for Smoothie, frozen product, 10/16oz. bags per case. UPC 0 11110 87853 3. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2206-2023·2023-07-26

    Medline O.R. Scissors Recalled Due to Sterile Packaging Compromise Risk

    Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.

    Product
    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

    Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0923-2023·2023-07-26

    Tizanidine Tablets Recalled Nationwide for Failed Dissolution Specification

    Dr. Reddy's Laboratories is recalling Tizanidine 4 mg tablets nationwide because 24-month stability testing revealed dissolution specification failures. No illnesses or injuries have been reported.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1284-2023·2023-07-26

    Fry Daddy's Gluten Free Ranch Party Mix recalled for undeclared walnut

    Fry Daddy's Gluten Free Ranch Party Mix is being recalled due to undeclared walnut allergen. The recall affects 1,356 retail units distributed in Michigan with sell-by dates from June 1 to December 31, 2023.

    Product
    Fry Daddy's Gluten Free Ranch Party Mix 10oz bag UPC 860007669576. 12 bags per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2191-2023·2023-07-26

    Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers

    Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2023·2023-07-26

    FDA Recalls RET Proximal Probe Laboratory Diagnostic Kits for Inverted DNA

    Cytocell Ltd. RET Proximal Probe kits distributed to laboratories in California, Florida, Ohio, and South Carolina are being recalled due to inverted DNA sequences introduced during manufacturing.

    Product
    RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2023·2023-07-26

    Medline ultrasound probe covers recalled for inadequate seam barrier

    Medline Probe Cover Kits used in diagnostic ultrasound procedures are recalled because probe covers may have an inadequate barrier at the seams, potentially allowing contamination.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2023·2023-07-26

    Medline Sterile Probe Covers Recalled for Inadequate Seam Barriers

    Medline is recalling 572 sterile probe cover kits due to inadequate barriers at the seams that may compromise sterility during ultrasound procedures. The affected products were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Defective Seam Barriers

    Medline Industries recalls probe cover kits used in diagnostic ultrasound procedures because the covers may have inadequate barriers at the seams. Approximately 3.7 million units are affected.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1253-2023·2023-07-26

    Three Apple Cider Brands Recalled for Patulin Contamination

    Bevovations, LLC is recalling apple cider from three brands—CN Smith, Wilson Farms, and Carlson Orchards—due to patulin contamination above FDA safety limits. Affected products were distributed in Massachusetts, Pennsylvania, Connecticut, and New Hampshire.

    Product
    1/2 gallon CN Smith brand Apple Cider; 1/2 gallon and 16 oz. Wilson Farms brand Apple Cider; 1 gallon, 1/2 gallon, and 16 oz. Carlson Orchards brand Apple Cider - all packaged in HDPE bottles and shipped in corrugated closed boxes.
    Category
    Food
    Distribution
    4 states
  • 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-2176-2023·2023-07-26

    Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

    Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Num
    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 (Devices)·Z-2205-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier

    Medline Industries is recalling 4,500 Probe Cover Kits because the covers have inadequate barriers at the seams, which may compromise sterility.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2023·2023-07-26

    Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

    Medline is recalling ultrasound probe cover kits containing sterile gel due to inadequate barriers at the seams, which may fail to maintain sterility during diagnostic procedures.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2023·2023-07-26

    RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences

    FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.

    Product
    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0931-2023·2023-07-26

    Norepinephrine injectable recalled due to sterility assurance concerns

    SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.

    Product
    Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2023·2023-07-26

    Medline Probe Cover Kits recalled for inadequate seam barrier

    Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.

    Product
    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
    Category
    Medical Device
    Distribution
    Distributed nationwide