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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28126–28150 of 40233

  • LowFDA (Devices)·Z-0722-2017·2016-12-14

    OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error

    OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.

    Product
    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0367-2017·2016-12-07

    Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure

    Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.

    Product
    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468…
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0660-2017·2016-12-07

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.

    Product
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0684-2017·2016-12-07

    MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.

    Product
    Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2017·2016-12-07

    Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results

    Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.

    Product
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2017·2016-12-07

    Hamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk

    Hamilton Medical is recalling 44 MR1 ventilators because the oxygen tubing and connector could become loose during preparation, potentially compromising ventilation support.

    Product
    Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays

    Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2017·2016-12-07

    Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes

    Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2017·2016-12-07

    Domain Surgical Recalls FMsealer Open Shears Due to Jaw Fractures

    Domain Surgical is recalling FMsealer Open Shears (Model FM3001) because fixed jaw fractures were observed during clinical usage.

    Product
    FMsealer Open Shears. Model FM3001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2017·2016-12-07

    MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve Cups because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2017·2016-12-07

    MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

    Product
    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns

    Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2017·2016-12-07

    Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns

    Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.

    Product
    OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2017·2016-12-07

    MicroPort Recalls Conserve Hip Shells Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve hip shells because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2017·2016-12-07

    B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing

    B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.

    Product
    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Aspiration System Trays Due to Sterility Concerns

    Teleflex Medical is recalling specific lots of Arrow OnControl Ported Aspiration System Trays because the outer sterile package may have an incomplete seal.

    Product
    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0681-2017·2016-12-07

    Synthes 0.76 mm Drill Bit Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 84 units of 0.76 mm Drill Bits that may be incorrectly labeled and actually contain 1.1 mm drill bits.

    Product
    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2017·2016-12-07

    MicroPort Orthopedics Recalls Lineage Liners Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling 5,009 Lineage Liners used with Conserve metal heads due to a suspected tissue reaction to metal debris.

    Product
    Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2017·2016-12-07

    Spectranetics Recalls Turbo Elite Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling Turbo Elite Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2017·2016-12-07

    Spectranetics Recalls ELCA Coronary Atherectomy Catheters Due to Packaging Integrity

    Spectranetics is voluntarily recalling ELCA Coronary Atherectomy Catheters and related devices because their outer sterile packaging may be compromised.

    Product
    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0668-2017·2016-12-07

    Elekta Monaco TRP System Software Recall for CT Data Handling Error

    Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.

    Product
    Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-0689-2017·2016-12-07

    MicroPort Recalls Cobalt Chromium Hip Replacement Heads Due to Metal Debris Risk

    MicroPort Orthopedics is recalling specific Cobalt Chromium hip replacement heads because internal data showed an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

    Product
    Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2017·2016-12-07

    Terumo BCT Recalls Adiprep Adipose Transfer System Due to Labeling Error

    Terumo BCT is voluntarily recalling 660 units of the Adiprep Adipose Transfer System because incorrect labeling could cause operator confusion.

    Product
    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2017·2016-12-07

    Siemens Recalls Z6Ms Transesophageal Transducers Due to Material Deterioration

    Siemens is recalling 33 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems because the material covering the articulating section has deteriorated, causing acquisition errors.

    Product
    Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0682-2017·2016-12-07

    Sorin Group Recalls Stöckert Heater Cooler System 3T for Disinfection Review

    Sorin Group USA is recalling Stöckert Heater Cooler System 3T units to ensure strict adherence to disinfection and monitoring instructions.

    Product
    ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart…
    Category
    Medical Device
    Distribution
    Distributed nationwide