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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25026–25050 of 40357

  • ModerateFDA (Devices)·Z-0654-2018·2018-02-28

    Arrow Multi Lumen CVC Kit Recalled for Incorrect Springwire Guide

    Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.

    Product
    Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2018·2018-02-28

    Arrow International Recalls Hemodialysis Catheterization Kits with Incorrect Guide

    Arrow International Inc is recalling specific lots of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2018·2018-02-28

    Oculus Pentacam AXL Software Recall for Erroneous Quality Markings

    Oculus Optikgeraete GmbH is recalling 83 Pentacam AXL devices due to a software anomaly that may produce erroneous quality specification markings.

    Product
    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0677-2018·2018-02-28

    Hologic Rapid for TLiIQ System Cassettes Recalled for Unapproved Material

    Hologic is recalling Rapid for the TLiIQ System cassettes because they were manufactured with material from a new supplier before FDA approval of the change.

    Product
    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0674-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

    Product
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2018·2018-02-28

    Medtronic CareLink iPro Software Recall for Time Conversion Error

    Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.

    Product
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0684-2018·2018-02-28

    Philips QCPR Meter Recall for CPR Instruction and Injury Information

    Philips is recalling QCPR meters to inform users of correct pad placement and injuries associated with CPR performance.

    Product
    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0665-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency

    Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 because complaints reported the material was too soft and sticky, causing unexpected handling during use.

    Product
    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0666-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

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

    Product
    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
    Category
    Medical Device
    Distribution
    0 states
  • 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