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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33401–33425 of 40325

  • ModerateFDA (Devices)·Z-1219-2015·2015-03-11

    Zimmer Segmental System Hip Stem Recalled for Coating Defect

    Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.

    Product
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1239-2015·2015-03-11

    CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling

    CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.

    Product
    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2015·2015-03-11

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.

    Product
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1228-2015·2015-03-11

    Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display

    Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.

    Product
    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1137-2015·2015-03-04

    Invacare TDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 1,942 TDX, FDX, and Storm Series power wheelchairs because wire pinching can cause smoking, sparking, or fire.

    Product
    TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure

    Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1131-2015·2015-03-04

    HeartWare Controller Recall Due to Higher Susceptibility to Electrostatic Discharge

    HeartWare Inc is recalling 4,845 HeartWare Controllers used in ventricular assist systems because they are more susceptible to electrostatic discharge (ESD) than newer models.

    Product
    HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2015·2015-03-04

    Invacare FDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 60 FDX, TDX, and Storm Series power wheelchairs because wire damage can cause smoking, sparking, or fire.

    Product
    FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2015·2015-03-04

    Invacare Electric Wheelchair Recall for Fire Hazard

    Invacare is recalling 525 electric wheelchairs because a seating defect can pinch wires, potentially causing smoking, sparking, or fire.

    Product
    Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps with Silent Alarm Defect

    Hospira is recalling 4,656 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1072-2015·2015-03-04

    Hospira Plum A+ Infusion Pump Alarm Assembly Recall

    Hospira is recalling 3,939 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1074-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Silent Alarm Defect

    Hospira is recalling nine Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1071-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Failing Alarm Assemblies

    Hospira Inc. is recalling 315 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at all volume levels.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1180-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Verification Issues

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Sterility Concerns

    Navilyst Medical is recalling 13 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 512 NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 541 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 10 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 180 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a risk of sterility breach and infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2015·2015-03-04

    Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 1,908 CoCr Femoral Heads due to potential sterile tray compromise. Undetected breaches could lead to contamination and periprosthetic infection.

    Product
    CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1215-2015·2015-03-04

    Brainlab Offset Cup Impactor Universal Recall Due to Sterilization Failure

    Brainlab AG is recalling 114 Offset Cup Impactor Universal units because their sterilization parameters are ineffective. The recall covers units distributed worldwide prior to January 13, 2015.

    Product
    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 69 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 255 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide