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.

44276–44300 of 50511

  • HighFDA (Devices)·Z-0531-2013·2012-12-26

    Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly

    Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.

    Product
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0540-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

    Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0840-2013·2012-12-26

    Mushroom Base Recalled for Missing Milk Allergen Labeling

    Williams West & Witt's Products Company is recalling Cook's Delight Mushroom Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #272N Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0494-2013·2012-12-26

    GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue

    GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.

    Product
    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain femoral heads.

    Product
    SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0835-2013·2012-12-26

    Lobster Base Recalled for Missing Milk Allergen Labeling

    Williams West & Witt's is recalling specific lobster base products because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #124-M Primarque Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #124-M Cook's Delight Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360 #124-M…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0603-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow rate issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0841-2013·2012-12-26

    Cook's Delight Shrimp Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Shrimp Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0600-2013·2012-12-26

    Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2013·2012-12-26

    BD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results

    Becton Dickinson is recalling 12,250 BD Phoenix PMIC-108 panels because they may produce false intermediate or resistant antibiotic susceptibility results.

    Product
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0591-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0843-2013·2012-12-26

    Primarque Lobster Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque Lobster Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0555-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0839-2013·2012-12-26

    Shrimp Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Shrimp Base because the label failed to identify milk as an ingredient.

    Product
    #428N Cook's Delight Shrimp Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0836-2013·2012-12-26

    Seafood Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque and Cook's Delight Seafood Base because the label failed to identify milk as an ingredient.

    Product
    #126 Primarque Seafood Base, Net Weight 16 oz, 1LB, 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #126 Cook's Delight Seafood Base, Net Weight 16 oz (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0580-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2013·2012-12-26

    Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0837-2013·2012-12-26

    Primarque Fish Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque Fish Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #425N Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0561-2013·2012-12-26

    BioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions

    BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.

    Product
    AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2013·2012-12-26

    Bayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2013·2012-12-26

    Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide