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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34401–34425 of 40325

  • HighFDA (Devices)·Z-0228-2015·2014-11-26

    Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

    Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0225-2015·2014-11-26

    Medacta MectaLIF Oblique Handle Recalled for Incorrect Laser Marking

    Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.

    Product
    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1583-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.

    Product
    DRAPE 9732722 TUBE STERILE O-ARM 20PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2014·2014-11-26

    Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    PATIENT TRACKER 9733534XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2014·2014-11-26

    Medtronic Recalls Sterile Drill Bits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BIT 9733516 2.9mm DRILL STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1599-2014·2014-11-26

    Medtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RES. PACK 9733553 AxiEM S.M.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    MOUSE 9732721 STERILE O-ARM 10PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2015·2014-11-26

    Siemens ADVIA Centaur Cleaning Solution Recalled for Stability Concerns

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.

    Product
    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2015·2014-11-26

    Edwards Lifesciences Recalls Vent Catheters Due to Stylet Coating Disruption

    Edwards Lifesciences is recalling Vent Catheters because the white plastic coating on the stylet may disrupt. The action covers 157,305 units distributed worldwide.

    Product
    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct…
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-1589-2014·2014-11-26

    Medtronic Recalls AxIEM CR Tumor Resection Devices Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    PACK 9731975 TUMOR RESECTION AXIEM CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1592-2014·2014-11-26

    Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PIN, 9733235, 100MM, STERILE, PERC REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733066, BIOPSY, INT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2014·2014-11-26

    Medtronic Recalls Thoracic Tactile Probes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    KIT, 9731427, THORACIC TACTILE PROBES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change

    Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.

    Product
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1584-2014·2014-11-26

    Medtronic Recalls ENT Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    ENT PRGM 9734636 ADD FUSION NAV AxiEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2014·2014-11-26

    Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RESECTION KIT 9733608 SKULL MOUNT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0229-2015·2014-11-26

    Siemens Recalls ADVIA Centaur BNP Assay Reagents Due to Labeling Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP Assay reagents because approximately 2,000 ReadyPacks contain an incorrect human-readable side label.

    Product
    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0230-2015·2014-11-26

    Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling

    Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.

    Product
    Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0231-2015·2014-11-26

    Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date

    Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration instead of 2 years.

    Product
    Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0233-2015·2014-11-26

    Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date

    Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.

    Product
    Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0232-2015·2014-11-26

    Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling

    Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration period instead of the correct 2-year period.

    Product
    Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0234-2015·2014-11-26

    Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date

    Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration instead of the correct 2-year period.

    Product
    Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0171-2015·2014-11-19

    Siemens MicroScan Rapid Urine Combo Panel Recalled for False Positive Results

    Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.

    Product
    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide