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.

26376–26400 of 50460

  • HighFDA (Devices)·Z-0945-2019·2019-03-06

    Arrow AutoFuser Pain Control Pump Recalled for Potential Cracks

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

    Product
    AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling AutoFuser Disposable Pain Control Pumps 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-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

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

    Product
    AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2019·2019-03-06

    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 and be pulled by the magnetic field.

    Product
    Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic 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 Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2019·2019-03-06

    Philips Ingenia 1.5T CX MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Ingenia 1.5T CX MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2019·2019-03-06

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

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

    Product
    Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2019·2019-03-06

    FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

    American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.

    Product
    Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0900-2019·2019-03-06

    Philips MRI System Recall Due to Falling Ceiling Speaker Hazard

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

    Product
    SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2019·2019-03-06

    Philips Achieva MRI System Recalled for Falling Ceiling Speaker Hazard

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

    Product
    Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2019·2019-03-06

    Elekta Recalls Monaco Radiation Treatment Planning System Software

    Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning System devices due to a software defect that may cause incorrect optimization models to be used during online plan adaptation.

    Product
    Monaco Radiation Treatment Planning (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0910-2019·2019-03-06

    Philips Ingenia 1.5T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Ingenia 1.5T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2019·2019-03-06

    Philips Intera 1.5T MRI System Recalled for Falling 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 CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2019·2019-03-06

    Philips Intera 1.5T MRI System Recalled for Falling Speaker Hazard

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

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because a manufacturing issue prevents them from threading properly with mating components.

    Product
    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet 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. Thoracolumbosacral pedicle screw system (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 Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2019·2019-03-06

    Philips Prodiva CS MRI System Recalled for Falling Speaker Hazard

    Philips is recalling Prodiva CS MRI systems because ceiling speakers may fall due to the magnetic field.

    Product
    Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International is recalling 38 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2019·2019-03-06

    Philips Multiva MRI System Recalled for Falling 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 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2019·2019-03-06

    Philips Intera 3.0T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Intera 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1098-2019·2019-03-06

    Aldi Bake Shop Lemon Loaf Cake Recalled for Undeclared Walnuts

    Gold Coast Bakery is recalling Aldi Bake Shop Lemon Loaf Cakes because they contain undeclared visible walnuts, a major food allergen.

    Product
    Aldi Bake Shop Lemon Loaf Cake 16 oz clear clam shell, 6 per tray (each tray includes 6 lemon loaf and 6 banana loaf) UPC 4099100018523
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0941-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

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

    Product
    AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps 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 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2019·2019-03-06

    Philips Panorama 1.0T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Panorama 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1100-2019·2019-03-06

    Nita Crisp Spelt Bread Cracker Recalled for Undeclared Wheat

    Nita Foods Inc. is recalling Nita Crisp Spelt Bread Crackers because the product contains undeclared wheat, a major food allergen.

    Product
    Nita Crisp Spelt Bread Cracker, 8- & 16-ounce bags, In paper bags with a plastic window and has a re-closable ability and safety sealed. Storage: Ambient & Dry
    Category
    Food
    Distribution
    6 states