The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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24951–24975 of 40233

  • LowFDA (Devices)·Z-0664-2018·2018-02-28

    LivaNova Recalls Sorin Group Smart Perfusion Packs Due to Incorrect Expiration Date

    LivaNova USA is recalling 16 units of Sorin Group Smart Perfusion Pack E-Packs because they are labeled with incorrect expiration dates.

    Product
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0667-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling

    Ivoclar Vivadent is recalling Heliomolar Refill units because complaints reported the material was too soft and sticky, causing unexpected handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0668-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling two units of Heliomolar Refill 20x0.25g 110T because the material was reported to be too soft and sticky, affecting handling.

    Product
    Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0607-2018·2018-02-21

    Sanofi Genzyme Recalls Synvisc-One Injections Due to Bacterial Contamination

    Sanofi Genzyme is recalling Synvisc-One injections due to contamination with Methylbacterium thiocyanatum. The recall affects 12,380 units distributed in 36 states.

    Product
    Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2018·2018-02-21

    Graham Medical SnugFit Mattress Cover Recalled for Potential Tearing

    Little Rapids Corporation is recalling Graham Medical SnugFit Expandable Mattress Covers because material defects may cause the cover to tear during lifting, posing a fall risk.

    Product
    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0565-2018·2018-02-21

    C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures

    C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.

    Product
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0563-2018·2018-02-21

    Kalila Medical Recalls Vado Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.

    Product
    Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0577-2018·2018-02-21

    Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization

    Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.

    Product
    Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0564-2018·2018-02-21

    Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.

    Product
    Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0596-2018·2018-02-21

    Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads

    Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.

    Product
    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2018·2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Absorber Seal

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

    Product
    Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0592-2018·2018-02-21

    Cepheid Recalls Xpert CT/NG Tests Due to Temperature Drift Errors

    Cepheid is recalling specific batches of Xpert CT/NG tests due to reports of higher-than-expected temperature drift errors and an occasional probability of false negative results.

    Product
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0568-2018·2018-02-21

    B. Braun Recalls Perifix Anesthesia Trays Due to Foreign Matter

    B. Braun Medical is recalling 700 Perifix Single Dose Epidural Anesthesia Trays because they contain loose polypropylene foreign matter above release specifications.

    Product
    Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2018·2018-02-21

    Zimmer Biomet Recalls G7 Dual Mobility Hip Liners Due to Labeling Error

    Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.

    Product
    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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