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.

2726–2750 of 88106

  • HighFDA (Devices)·Z-2049-2026·2026-05-13

    LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure

    Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.

    Product
    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0707-2026·2026-05-13

    Darkside of the Hive lemon creamed honey may contain metal fragments

    Lemon Creamed Honey from Darkside of the Hive is being recalled because it may contain stainless steel dust or flakes and small particles or shreds of plastic.

    Product
    Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2121-2026·2026-05-13

    Medline Convenience Kits General Closure sterilization calibration issue

    Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.

    Product
    Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2026·2026-05-13

    One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step pH in vitro diagnostic test REF: 31I4P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0759-2026·2026-05-13

    Store-label peppermint ice cream contains undeclared Red #40

    Peppermint Ice Cream sold under four store labels is being recalled because it contains undeclared Red #40. 1,076 units are affected.

    Product
    Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2122-2026·2026-05-13

    Medline Convenience Kits sterilization calibration issue recalled

    Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall

    Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps instructions for use correction

    Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2026·2026-05-13

    One Step K in vitro diagnostic test recall for missing FDA clearance

    DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.

    Product
    One Step K in vitro diagnostic test REF: 81A4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0689-2026·2026-05-13

    XZL jelly snacks contain undeclared FD&C yellow and red colors

    XZL Jelly Snacks in 12.68 oz bags are being recalled because the product contains undeclared FD&C Yellow #5, Yellow #6 and Red #40. 100 cases are affected.

    Product
    XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0520-2026·2026-05-13

    Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities

    JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0696-2026·2026-05-13

    SunRidge Farms organic chili bean blend recalled over pesticide contamination

    SunRidge Farms Organic Chili Bean Blend in 15 lb cases is being recalled over potential contamination with the pesticides haloxyfop and thiamethoxam.

    Product
    SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0514-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps require instructions-for-use correction

    Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.

    Product
    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2026·2026-05-13

    Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instructions update

    Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2026·2026-05-13

    Medline Convenience Kits Recalled for Potential Sterilization Calibration Issues

    Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.

    Product
    See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2105-2026·2026-05-13

    Medline Admit Kit DYKA1343A Medical Device Recall

    Medline is recalling Admit Kits (Model DYKA1343A) due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2026·2026-05-13

    Uric Acid in vitro diagnostic test distributed without FDA clearance

    DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.

    Product
    Uric Acid in vitro diagnostic test REF: 31H0P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0697-2026·2026-05-13

    SunRidge Farms organic soup mix recalled over potential pesticide contamination

    SunRidge Farms Organic Sunset Soup Mix in 25 lb cases is being recalled over potential contamination with the pesticides haloxyfop and thiamethoxam.

    Product
    SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2132-2026·2026-05-13

    ZENBONE Resorbable Bone Void Filler Recall Outside Specifications

    Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.

    Product
    ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
    Category
    Medical Device
    Distribution
    Distributed nationwide