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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23576–23600 of 40299

  • ModerateFDA (Devices)·Z-2080-2018·2018-06-13

    Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.

    Product
    ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2018·2018-06-13

    NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

    NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

    Product
    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2018·2018-06-13

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

    Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

    Product
    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2018·2018-06-13

    Medtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues

    Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.

    Product
    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2091-2018·2018-06-13

    Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2018·2018-06-13

    Hobbs Bronchial Cytology Brushes Recalled for Unauthorized Marketing

    Hobbs Medical is recalling 1,820 bronchial cytology brushes because they were marketed for uses outside their FDA clearance.

    Product
    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2018·2018-06-13

    Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2018·2018-06-13

    Tosoh ST-AIA PACK T4 Thyroid Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2105-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2104-2018·2018-06-13

    Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure

    Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2106-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1928-2018·2018-06-06

    Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps

    Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.

    Product
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2036-2018·2018-06-06

    Recall of Sterile Powdered Surgical Gloves Due to Banned Powder Content

    WRP Asia Pacific Sdn Bhd is recalling 201,000 pairs of AmerisourceBergen sterile surgical gloves because some left-handed gloves contain powder, which is banned in the U.S.

    Product
    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2039-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2035-2018·2018-06-06

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure

    Philips is recalling five HeartStart MRx monitor/defibrillators because a faulty circuit board may prevent charging, potentially delaying life-saving therapy.

    Product
    HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2048-2018·2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2041-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2018·2018-06-06

    Gyrus ACMI Reusable Active Cord Recalled for Fire Hazard

    Gyrus Acmi is recalling 6,447 reusable active cords for electrosurgical generators due to a potential risk of sparking and causing a fire.

    Product
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1903-2018·2018-06-06

    Heartware Medtronic HVAD System Recalled for Transient Electrical Interruptions

    Heartware is recalling HVAD System components due to possible transient electrical connection interruptions that may cause unexpected beeping or power switching.

    Product
    Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2018·2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device discontinuous or open.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 Single-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2018·2018-06-06

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
    Category
    Medical Device
    Distribution
    Distributed nationwide