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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15626–15650 of 39988

  • HighFDA (Devices)·Z-0547-2021·2020-12-16

    Randox Rx Series Mg Magnesium Test Kits Recalled for Performance Failure

    Randox Laboratories is recalling four kits of the Rx Series Mg Magnesium test due to reduced linearity performance.

    Product
    Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2021·2020-12-16

    Shimadzu Mobile X-Ray System Recalled for Improper Handle Bolts

    Shimadzu Medical Systems is recalling 115 Mobile X-Ray Systems because the adjustable handle may have improper bolts, posing a risk of harm to individuals around the device.

    Product
    Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2021·2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2021·2020-12-16

    Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

    Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

    Product
    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2021·2020-12-16

    Randox Mg R1 Magnesium Test Kit Recalled for Linearity Performance Failure

    Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.

    Product
    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0535-2021·2020-12-16

    LivaNova Recalls VNS Therapy SENTIVA DUO Generators Due to Model Number Error

    LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.

    Product
    VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0536-2021·2020-12-16

    Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test results.

    Product
    3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2021·2020-12-16

    Integra Recalls Mayfield A2000 Skull Cap Instruction Manual

    Integra LifeSciences Corp. is recalling 552 instruction manuals for the Mayfield A2000 Skull Cap to correct inaccurate illustrations.

    Product
    Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2021·2020-12-16

    BD Multi-Check CD4 Low Control Recalled for Inaccurate Flow Cytometry Results

    Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.

    Product
    BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2021·2020-12-16

    Welch Allyn ELI 380 Electrocardiograph Recalled for Wireless Disconnection

    Welch Allyn is recalling 1,009 ELI 380 Electrocardiographs because the internal radio can disconnect from the wireless access point.

    Product
    ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2021·2020-12-16

    Canon CT Scanner Recall for Software Issue Causing Scan Failures

    Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.

    Product
    Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0563-2021·2020-12-16

    Spacelabs Sentinel V10 and V11 Software Upgrade Recall

    Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.

    Product
    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2021·2020-12-09

    Invacare PerfectO2 V Oxygen Concentrator Recalled for Fire and Explosion Risk

    Invacare is recalling 384,767 PerfectO2 V oxygen concentrators worldwide due to a defect that may cause self-extinguishing fires or cap explosions.

    Product
    Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0526-2021·2020-12-09

    CME America Recalls NeoThrive Syringe Pumps Due to Motor Wear

    CME America is recalling 4,182 NeoThrive syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0518-2021·2020-12-09

    Medtronic MiniMed 640G Insulin Pump Recalled for Missing Solder Battery Connection

    Medtronic is recalling MiniMed 640G insulin pumps because a missing solder battery connection could interrupt power. The recall covers specific serial numbers distributed in the U.S. and abroad.

    Product
    MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0527-2021·2020-12-09

    CME America T-Syringe Pump Recall for Motor Wear and Fluid Damage

    CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0516-2021·2020-12-09

    Medtronic MiniMed 670G Insulin Pumps Recalled for Battery Connection Defect

    Medtronic is recalling 391 MiniMed 670G insulin pumps because a missing solder battery connection could interrupt power to the device.

    Product
    MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2021·2020-12-09

    Verathon BladderScan Prime Plus Probe Recall for Handle Cracking Risk

    Verathon is recalling 398 BladderScan Prime Plus Probes because a change in handle material and process may cause the handle to crack.

    Product
    BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2021·2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage

    CME America is recalling T-Syringe Pumps because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2021·2020-12-09

    VEO Diagnostics Recalls ACCEL ELISA COVID-19 Antibody Test Kits

    VEO Diagnostics is recalling 15 ACCEL ELISA COVID-19 antibody test kits because the FDA removed their Emergency Use Authorization. Users should stop using the kits.

    Product
    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
    Category
    Medical Device
    Distribution
    Distributed nationwide