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.

26351–26375 of 50460

  • HighFDA (Devices)·Z-0903-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Fall Risk

    Philips is recalling SmartPath to dStream MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2019·2019-03-06

    Philips Ingenia 3.0T MRI Systems Recalled for Ceiling Speaker Hazard

    Philips is recalling 11,226 Ingenia 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2019·2019-03-06

    Philips Multiva MRI System Recalled Due to Ceiling Speaker Hazard

    Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2019·2019-03-06

    Philips MRI System Recall Due to Falling Ceiling Speaker Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1055-2019·2019-03-06

    Craft Granola Goldenola Turmeric & Ginger Recalled for Undeclared Cashews

    Birdseed Food Co LLC is recalling Craft Granola Goldenola Turmeric & Ginger due to visible undeclared whole cashews. The product was distributed in six states.

    Product
    Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz. and 11 oz. poly bag, UPC: 860157002028 and 8601570020135
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0882-2019·2019-03-06

    Philips Enterprise 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling Enterprise 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2019·2019-03-06

    Philips Achieva 3.0T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2019·2019-03-06

    Philips Multiva 1.5T MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2019·2019-03-06

    Philips Achieva 3.0T X MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 3.0T X MRI systems because ceiling speakers may fall due to the magnetic field.

    Product
    Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0908-2019·2019-03-06

    Philips Intera 1.5T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2019·2019-03-06

    Organon Teknika Recalls Vitek 2 Reagent Cards Due to Seal Integrity Issues

    Organon Teknika Inc is recalling 129,321 cartons of Vitek 2 reagent cards worldwide due to compromised top seal integrity that may cause inaccurate test results.

    Product
    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0867-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may be pulled by the magnetic field and fall.

    Product
    Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2019·2019-03-06

    Philips Ingenia 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Ingenia 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V180000·2019-03-06

    Porsche Recalls 2018 Panamera Models Due to Electrical Control Unit Defect

    Porsche is recalling 2018 Panamera models because incorrect soldering on a control unit may cause intermittent system failures and impaired driveability.

    Product
    PORSCHE — PORSCHE PANAMERA TURBO SPORT TURI, PANAMERA 4S EXECUTIVE, PANAMERA TURBO S HYBRID E, PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2019·2019-03-06

    Philips Achieva 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc is recalling specific Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2019·2019-03-06

    Philips Ingenia 1.5T MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Ingenia 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2019·2019-03-06

    Philips Achieva 1.5T MRI System Recalled Due to Falling Speaker Hazard

    Philips Medical Systems is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2019·2019-03-06

    Philips Prodiva CX MRI Systems Recalled for Ceiling Speaker Hazard

    Philips is recalling Prodiva CX MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 19 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Fall Risk

    Philips is recalling Intera 1.5T Achieva CV Nova MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide