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.

23426–23450 of 50435

  • HighFDA (Devices)·Z-1554-2020·2020-04-01

    Hill-Rom Recalls NaviCare Patient Safety Software Due to Bed Exit Mechanism Failure

    Hill-Rom Inc. is recalling NaviCare Patient Safety Software versions 3.5.400-3.9.300 because a software issue may cause the patient bed exit mechanism to fail to monitor or control.

    Product
    NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1531-2020·2020-04-01

    Karl Storz Flexible Neuroscopes Recalled Due to Sterilization Manual Error

    Karl Storz is recalling 42 flexible neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.

    Product
    Karl Storz, Model # 11161C2, Flexible Neuroscope
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1588-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 225,498 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2020·2020-04-01

    Abbott Alinity ci-series Software Recalled for Performance Issues

    Abbott is recalling Alinity ci-series software version 2.6.2 and earlier due to identified potential performance issues.

    Product
    LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2020·2020-04-01

    Biomet Recalls Misidentified 9mm Shoulder Mini Humeral Stem Implants

    Biomet is recalling 14 units of 9mm Shoulder Mini Humeral Stems that were misidentified as 15mm units. The error poses a risk of improper surgical implantation.

    Product
    Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1560-2020·2020-04-01

    Dexcom G4 Platinum Recall Due to Hydroxyurea Interference

    Dexcom Inc is recalling G4 PLATINUM systems because hydroxyurea use may cause falsely elevated glucose readings.

    Product
    Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1595-2020·2020-04-01

    Medtronic MiniMed Paradigm Veo Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2020·2020-04-01

    Medline Recalls Sterile Syringes Due to Packaging Seal Voids

    Medline Industries is recalling 3,690 units of sterile 3mL syringes because voids in the packaging seal caused a loss of sterility.

    Product
    Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0915-2020·2020-04-01

    Southern Sisters Gourmet Shrimp and Grits Recalled for Undeclared Milk

    Southern Sisters Gourmet is recalling Shrimp and Stone-Ground Grits due to undeclared milk and colors. The product was distributed in nine southern states.

    Product
    Southern Sisters Gourmet Shrimp and Stone-Ground Grits, Seasoning - Net Wt: 12 g, Grits - Wt: 8 ounces
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1581-2020·2020-04-01

    Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 64,174 MiniMed Insulin Pumps (model MMT-508) due to potential cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    MiniMed Insulin Pump, model # MMT-508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0917-2020·2020-04-01

    Southern Sisters Gourmet Taco Soup Recalled for Undeclared Allergens

    Southern Sisters Gourmet Taco Soup is being recalled because it contains undeclared milk and soy. The product was distributed in nine states.

    Product
    Southern Sisters Gourmet Taco Soup, Net Wt- Pkg 1: 191.65 g, Pkg 2: 8 ounces
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1584-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

    Medtronic MiniMed is recalling 74,496 MiniMed Paradigm Insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    MiniMed Paradigm Insulin pump, model number MMT-712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2020·2020-04-01

    RayStation software recall due to virtual wedge field limitations

    RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.

    Product
    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 17 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2020·2020-04-01

    Carroll-Baccari Recalls Wave Prep Tubes and Cups Due to Contamination

    Carroll-Baccari, Inc. is recalling Wave Prep Tubes and single-use cups found to be contaminated with Burkholderia cepacia during an FDA inspection.

    Product
    Wave Prep Tubes (1710-03) and single use cups (17--00-24)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2020·2020-04-01

    Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions

    Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.

    Product
    Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2020·2020-04-01

    Bard PowerPort isp MRI Implantable Port Recall for Incorrect Catheter Barb Tip

    Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2020·2020-04-01

    Medtronic MiniMed Paradigm Veo Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 2,322 Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0856-2020·2020-04-01

    WinCo Foods Recalls Frozen Blackberries Due to Norovirus Contamination

    WinCo Foods is recalling 16-ounce bags of frozen blackberries found to be adulterated with Norovirus. The product was distributed in ten western and central states.

    Product
    WinCo Foods frozen Blackberries, item # 107414, packaged in polyethylene bags, with a net weight of 16 oz (1 lb or 454g). UPC: 70552 30502. Product is distributed by WinCo Foods, LLC, Boise, ID 83704. The label is read in parts: "***WinCo Foods***Blackberries*** INGREDIENTS…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1562-2020·2020-04-01

    Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.

    Product
    Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
    Category
    Medical Device
    Distribution
    0 states