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.

8276–8300 of 52968

  • 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 (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-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 (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-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-2187-2024·2024-07-03

    X-ray table recalled for fire hazard from power supply unit short circuit

    Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.

    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: 475525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1428-2024·2024-07-03

    Cream Cheese Stuffed Mini Bagels Recalled for Undeclared Gluten

    FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Everything Mini Bagels nationwide because the product contains gluten not listed on the label. Consumers with gluten sensitivity should not consume this product.

    Product
    Cream Cheese Stuffed Everything Mini Bagels
    Category
    Food
    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
  • HighFDA (Devices)·Z-2200-2024·2024-07-03

    Medtronic PRIMO MRI DR SureScan Cardioverter Defibrillators Recalled for Manufacturing Defect

    Medtronic is recalling two PRIMO MRI DR SureScan implantable cardioverter defibrillators due to a potential manufacturing defect involving weld cracks detected during manufacturing quality testing.

    Product
    PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2024·2024-07-03

    Siemens AXIOM Vertix Solitaire Display Fire Risk from Power Supply Short Circuit

    Siemens is recalling the AXIOM Vertix Solitaire diagnostic imaging component due to a short circuit in the Touch Display's power supply unit that may cause overheating and fire. Two units with serial numbers 1239 and 1241 are affected.

    Product
    ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack

    Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.

    Product
    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2024·2024-07-03

    Siemens X-ray Table Recalled for Fire Hazard in Power Supply

    Siemens recalls AXIOM MULTIX MT radiographic X-ray tables due to a short circuit in the power supply unit that may cause overheating and fire. 7 units are affected nationwide.

    Product
    AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415
    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-2203-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.

    Product
    PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2024·2024-07-03

    Medtronic MIRRO MRI implantable defibrillator recalled for weld defect

    Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 (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-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-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-2197-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.

    Product
    EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2024·2024-07-03

    Implantable Defibrillator Recalled for Manufacturing Weld Crack Defect

    Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.

    Product
    COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide