The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

10976–11000 of 22147

  • HighFDA (Drugs)·D-0565-2024·2024-07-03

    Injectable Labetalol Hydrochloride Recalled Due to Incomplete Crimp Seals

    Pfizer recalls 220,400 cartridges of Labetalol Hydrochloride injection due to potential incomplete crimp seals that could compromise sterility. Affected lots should not be used; healthcare providers should contact Pfizer for guidance.

    Product
    LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-2209-2024·2024-07-03

    Implantable defibrillator recalled for manufacturing defect causing device failure risk

    Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.

    Product
    Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1419-2024·2024-07-03

    Gluten-Contaminated Aussie Bites Bakery Product Recall Due to Allergen Mislabeling

    Universal Bakery Organic Aussie Bites are being recalled because they are labeled as gluten-free but testing found gluten content above 20 parts per million. The product was distributed to Washington and Illinois.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·24V184000·2024-07-03

    2023 Honda Ridgeline and Passport steering gearbox may detach

    Honda is recalling certain 2023 Ridgeline and Passport vehicles because the steering gearbox inner ball joint housing may loosen and detach, potentially causing loss of steering control.

    Product
    HONDA — 2023 HONDA RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1408-2024·2024-07-03

    Frozen Sausage, Egg & Cheese Biscuits Recalled for Possible Listeria Contamination

    Wakefield Sausage, Egg & Cheese Biscuit (Item 806638) has been recalled in 14 states due to possible Listeria monocytogenes contamination. Affected products have best-by dates from February 2024 through March 2025.

    Product
    (Item 806638) Wakefield Sausage, Egg & Cheese Biscuit
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1427-2024·2024-07-03

    Cream Cheese Stuffed Plain Mini Bagels Recalled for Undeclared Gluten

    FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Plain Mini Bagels due to undeclared gluten. Consumers with gluten sensitivity or celiac disease should not consume this product.

    Product
    Cream Cheese Stuffed Plain Mini Bagels
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2024·2024-07-03

    Medtronic COBALT DR MRI ICD Recalled for Manufacturing Defect

    Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.

    Product
    COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2024·2024-07-03

    Infinity M500 Cardiac Monitor Poses Electrical Shock Risk

    Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.

    Product
    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2024·2024-07-03

    Medtronic COBALT XT HF CRT-D implantable defibrillator recalled for manufacturing defects

    Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.

    Product
    COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1410-2024·2024-07-03

    Wakefield Charbroiled Cheeseburgers Recalled Due to Listeria Contamination Risk

    Classic Delight LLC is recalling 1,626 cases of Wakefield Charbroiled Cheeseburgers due to potential Listeria monocytogenes contamination. The product was distributed to 14 states; consumers should discard affected items.

    Product
    (Item 806679) Wakefield Charbroiled Cheeseburger
    Category
    Food
    Distribution
    0 states
  • HighCPSC·24291·2024-07-03

    Hatch Baby Power Adapters for Rest 1st Generation Sound Machines Pose Shock Hazard

    Hatch Baby is recalling power adapters sold with Rest 1st Generation sound machines because the plastic housing can detach from the adapter when unplugged, exposing electrical prongs and creating a shock hazard. The firm has received 19 reports of the housing coming off, including two reports of minor electrical shock.

    Product
    Power Adapters sold with Rest 1st Generation sound machines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1409-2024·2024-07-03

    Classic Delight Sausage, Egg & Cheese Muffins Recalled for Listeria Risk

    Classic Delight LLC is recalling Wakefield Sausage, Egg & Cheese Muffins (Item 806646) distributed across 14 states due to possible Listeria monocytogenes contamination.

    Product
    (Item 806646) Wakefield Sausage, Egg & Cheese Muffin
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1421-2024·2024-07-03

    Tillamook Cheese Slices Recalled Due to Plastic Fragments

    Tillamook Colby Jack/Monterey Jack Cheese Slices are being recalled due to plastic material found in the cheese. Consumers in Washington and Utah should not consume this product.

    Product
    Tillamook Colby Jack/Monterey Jack Cheese Slices, item # 651195, net wt. 32oz, total 42 slices per package, refrigerated, packaged in flexible plastic film, retail package UPC 0 72830 00721 4. Case Item #82721, 12/2lb (32oz) packages per case. Case UPC 0 00 72830 82721 8. Tillam
    Category
    Food
    Distribution
    2 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 (Food)·F-1429-2024·2024-07-03

    Lidl Chef Select Garlic Baguettes Recalled for Undeclared Wheat and Milk Allergens

    Lidl US TRADING is recalling Chef Select 2 Garlic Baguettes due to undeclared wheat and milk allergens caused by foreign language labeling. Consumers with allergies to wheat or milk should not consume these products.

    Product
    Chef Select 2 Garlic Baguettes filled With Garlic Butter 2x175 g Barcode: 4056489447559. Frozen product packaged in a plastic bag, 2 baguettes per unit.
    Category
    Food
    Distribution
    9 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 (Food)·F-1414-2024·2024-07-03

    Wakefield Sausage and Egg Pancake Recalled for Possible Listeria Contamination

    Classic Delight LLC recalls Wakefield Sausage & Egg Pancake products (Item 942821) due to possible Listeria monocytogenes contamination. Affected products were distributed across 14 states.

    Product
    (Item 942821) Wakefield Sausage & Egg Pancake
    Category
    Food
    Distribution
    0 states
  • 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-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 (Devices)·Z-2170-2024·2024-07-03

    Patient Monitors May Fail to Display Vitals After Power Loss

    GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
    Category
    Medical Device
    Distribution
    0 states