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.

10776–10800 of 27206

  • HighFDA (Food)·F-1426-2024·2024-07-03

    Chocolate Chunk Cookie Mix Recalled for Undeclared Coconut Allergen

    Penguin Natural Foods is recalling 'THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen' because the product contains undeclared coconut. Consumers with coconut allergies face a serious health risk.

    Product
    "THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen NET WT. 15.76 OZ (447g)" Packaged in a beige cardboard box, with green lettering
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2190-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.

    Product
    COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2024·2024-07-03

    Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects

    Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.

    Product
    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect

    Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2024·2024-07-03

    GE CARESCAPE Canvas monitors may lose display following power loss events

    GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.

    Product
    CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2221-2024·2024-07-03

    Endoscopic Kittner Surgical Instrument Recalled for Sterile Barrier Defect

    ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.

    Product
    Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2024·2024-07-03

    Prelude Roadster Guide Sheaths Recalled Due to Instruction Defect

    Merit Medical Systems is recalling Prelude Roadster Guide Sheaths due to an instructional defect. Older instructions directing tight connection assembly may cause over-tightening, leading to swivel nut detachment.

    Product
    Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2024·2024-07-03

    Siemens Multix TOP X-ray Table Recalled Due to Fire Risk

    Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2024·2024-07-03

    Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect

    Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.

    Product
    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1405-2024·2024-07-03

    Wakefield Ham, Egg & Cheese Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 1,366 cases of Wakefield Ham, Egg & Cheese Muffins due to possible Listeria monocytogenes contamination. The affected products were distributed across 14 states.

    Product
    (Item 806604) Wakefield Ham, Egg & Cheese Muffin
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1423-2024·2024-07-03

    Fresh Catch Inc. Yellowfin Tuna Recalled for High Histamine Levels

    Fresh Catch Inc. is recalling Yellowfin Tuna for high histamine levels. No illnesses have been reported.

    Product
    Fresh Catch Inc. Yellowfin Tuna, 1 loin per case packaged in carboard boxes with keep refrigerated label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2171-2024·2024-07-03

    GE CARESCAPE Monitors May Fail to Power On After Battery Replacement

    GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-0103
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2214-2024·2024-07-03

    RAPIDPoint 500e diagnostic system mislabels capillary blood samples as arterial

    Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.

    Product
    Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2024·2024-07-03

    Dental Scaler Tip May Not Seat Properly, Posing Injury Risk

    Dental EZ Group is recalling certain Titan Scaler Tip (Perio, Model 261669) units due to an oversized tip holder condition that may prevent proper seating, creating a risk of injury during use.

    Product
    Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2024·2024-07-03

    CARESCAPE Patient Monitors May Not Power On After Battery Replacement

    Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1402-2024·2024-07-03

    Wakefield Charbroiled Cheeseburger Kaiser Roll Recalled for Listeria Contamination

    Classic Delight LLC is recalling 3,411 cases of Wakefield Charbroiled Cheeseburger Kaiser Roll due to possible Listeria monocytogenes contamination. The product was distributed in 14 states.

    Product
    (Item 514713) Wakefield Charbroiled Cheeseburger Kaiser Roll
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1416-2024·2024-07-03

    Turkey Sausage & Egg Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 16,572 cases of Turkey Sausage & Egg Muffins (Item 73131) distributed across 14 states due to possible Listeria monocytogenes contamination.

    Product
    (Item 73131) Turkey Sausage & Egg Muffin
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2169-2024·2024-07-03

    GE CARESCAPE Canvas Smart Display monitors may fail to restart after power loss

    GE CARESCAPE Canvas Smart Display monitors may fail to turn on after a power loss, particularly following battery replacement, potentially delaying recognition of patient condition changes.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2167-2024·2024-07-03

    FDA Recalls CUSA Excel Surgical Handpiece for Housing Cracks

    Integra LifeSciences is recalling CUSA Excel C2600 surgical handpieces due to potential housing cracks that may delay treatment. The recall affects 2,652 units distributed nationwide and internationally.

    Product
    CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2024·2024-07-03

    Drainage Catheter Recalled Due to Incorrect Expiration Dates on Labels

    Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter due to incorrect expiration dates on product labels that extend beyond the device's true expiration date. Affected units were distributed to Spain and the Netherlands.

    Product
    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2179-2024·2024-07-03

    RingLoc Hip Acetabular Cup Recalled for Assembly Defect

    Biomet recalled RingLoc hip acetabular cup components that may have been incorrectly assembled with a mismatched locking ring, potentially causing joint instability. Affected patients may require surgical intervention.

    Product
    RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2024·2024-07-03

    Medical imaging system recalled for power supply fire risk

    Siemens is recalling 2 AXIOM Vertix MD imaging systems nationwide due to a potential fire hazard from a short circuit in the power supply unit that may cause overheating.

    Product
    AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0563-2024·2024-07-03

    Progesterone 200 mg compounded tablets recalled for embedded metal fragments

    Coast Quality Pharmacy is recalling Progesterone 200 mg compounded sublingual tablets nationwide due to discovery of broken metal pieces embedded in tablets. Patients should contact their healthcare provider.

    Product
    Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
    Category
    Drug
    Distribution
    Distributed nationwide