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.

29826–29850 of 50499

  • HighFDA (Devices)·Z-0625-2018·2018-02-21

    Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Software Bug

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a software bug may cause incorrect unit changes, risking inaccurate blood glucose data or carbohydrate input.

    Product
    Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0591-2018·2018-02-21

    Aesculap Vega Knee Trial Plateau Recalled for Incorrect Labeling

    Aesculap is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4 due to incorrect labeling. Using the wrong size could lead to implantation errors, ligament injury, pain, or revision surgery.

    Product
    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2018·2018-02-21

    3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.

    Product
    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2018·2018-02-21

    Hologic Panther Fusion Recalled Due to Falling Glass Panel Hazard

    Hologic is recalling 103 Panther Fusion instruments because the glass panel may separate from the monitor and fall, potentially striking an operator.

    Product
    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0820-2018·2018-02-21

    Hanover Foods Recalls Frozen Sliced Squash for Listeria Risk

    Hanover Foods is recalling 180,900 lbs of frozen sliced squash found positive for Listeria monocytogenes. The product was distributed in Pennsylvania.

    Product
    Frozen Sliced (blanched) Squash packed in 1400 lb. plastic totes.
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18104·2018-02-21

    Yayi Outdoor Gas Fire Pit Tables Recalled for Burn Hazard

    Yayi is recalling Hampton Bay outdoor gas fire pit tables sold at Home Depot because the bowl base lacks a heat shield, posing a burn risk.

    Product
    Outdoor Gas Fire Pit Table Patio Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2018·2018-02-21

    Zimmer Biomet Recalls BlockAid Cut Resistant Surgical Glove Liners

    Zimmer Biomet is recalling BlockAid Cut Resistant Surgical Glove Liners because the product lacks sterility assurance. The recall affects 1,863 units distributed in 29 states and three countries.

    Product
    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0628-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implants

    Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2018·2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Seal

    GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0603-2018·2018-02-21

    Exactech Orthopedic Surgical Tool Recalled for Fracture Risk

    Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.

    Product
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0627-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implant Devices

    Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2018·2018-02-21

    3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.

    Product
    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2018·2018-02-21

    Hemotherm Dual Reservoir Cooler/Heater System Recall for Updated Cleaning Instructions

    Cincinnati Sub-Zero is recalling 1,355 Hemotherm units to provide updated instructions for cleaning and disinfection to address NTM infection risks.

    Product
    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V124000·2018-02-20

    Navistar Recalls 2016-2019 IC Bus CE School Buses for Relay Defect

    Navistar is recalling 2016-2019 IC Bus CE school buses with 8.8L LPG engines because a relay may fail, causing the fuel pump to stop and the bus to stall.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V120000·2018-02-19

    Thor Motor Coach Recalls Outlaw RVs Due to Seat Belt Bracket Defect

    Thor Motor Coach is recalling 2018-2019 Outlaw model 29J recreational vehicles because the sofa seat belt bracket may not meet strength requirements, increasing injury risk in a crash.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V117000·2018-02-17

    Nova Bus Recalls 2013 LFS Transit Buses for Cooling System Defect

    Nova Bus is recalling 2013 LFS transit buses because a transmission oil cooler failure could cause hot coolant to leak into the passenger area, posing a risk of injury.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V113000·2018-02-15

    Mercedes-Benz Recalls Sprinter Vans Due to Incorrect Weight Labels

    Daimler Vans USA is recalling 2016-2017 Mercedes-Benz Sprinter 2500 and 3500 vans with folding seats because the unloaded vehicle weight label may be incorrect, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V109000·2018-02-14

    Lance Recalls 2018 Recreational Trailers Due to Power Tongue Jack Defect

    Lance is recalling 2018 recreational trailers because a power tongue jack touch pad may crack, allowing water entry and causing the jack to operate unintentionally.

    Product
    LANCE — LANCE 1995, 2465, 2185, 2285
    Category
    Vehicle
    Distribution
    Distributed nationwide