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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21326–21350 of 40248

  • HighFDA (Devices)·Z-0849-2019·2019-02-27

    Baxter AMIA Automated Peritoneal Dialysis System Software Recall

    Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.

    Product
    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2019·2019-02-27

    Shimadzu TRINIAS Imaging Systems Recalled for Software and Display Errors

    Shimadzu is recalling 13 TRINIAS imaging systems due to software crashes and rare display corruption that may hinder medical examinations.

    Product
    TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0847-2019·2019-02-27

    bioMerieux Recalls VITEK 2 AST-N351 Test Kits Due to False Positives

    bioMerieux, Inc. is recalling VITEK 2 AST-N351 Test Kits distributed in the UK and Ireland because they may produce false positive results for ESBL phenotypes.

    Product
    VITEK 2 AST-N351 Test Kit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0845-2019·2019-02-27

    Medtronic Power Supply and Programmer Recall for Electrical Short Risk

    Medtronic is recalling 731 Power Supply 26907 and CareLink Encore 29901 Programmer units due to a potential electrical short circuit that can cause heating and smoke.

    Product
    Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0848-2019·2019-02-27

    Ortho-Clinical Diagnostics Recalls VITROS VALP Reagent Packs Due to Negative Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VALP Reagent Packs because they may produce negative bias results when measuring valproic acid.

    Product
    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2019·2019-02-27

    Boston Scientific Recalls Mislabelled Stingray Guidewires for Coronary Procedures

    Boston Scientific is recalling 49 Stingray Guidewires that are 185cm but incorrectly labeled as 300cm. The mislabeling could lead to improper use during angioplasty procedures.

    Product
    Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2019·2019-02-27

    Ortho Vitros Myoglobin Calibrators Recalled for Stability Issues

    Ortho Clinical Diagnostics is recalling Vitros Myoglobin Calibrators due to a stability issue that may cause calibration failures or atypical quality control results.

    Product
    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0839-2019·2019-02-27

    Randox Calcium Reagent Recall for Potential Carryover Errors

    Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover, which may cause inaccurate test results.

    Product
    Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0842-2019·2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads

    Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    Product
    Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2019·2019-02-27

    Leica PROVEO 8 Ophthalmic Microscope System Recalled for Software Defects

    Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.

    Product
    PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0840-2019·2019-02-27

    Randox Calcium Reagent Recall for Potential Carryover Errors

    Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover. This issue may cause falsely elevated or decreased results in patient and QC samples.

    Product
    Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0843-2019·2019-02-27

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Iodine Potency

    Smiths Medical ASD Inc. is recalling Portex Pulsator Arterial Blood Sampling Kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.

    Product
    Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0830-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

    AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0832-2019·2019-02-20

    AtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk

    AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0812-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.

    Product
    vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0811-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0809-2019·2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0808-2019·2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0810-2019·2019-02-20

    Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error

    Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.

    Product
    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0806-2019·2019-02-20

    Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0807-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.

    Product
    Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0824-2019·2019-02-20

    Steris ATLAS Loading Car Recalled for Latch Failure Risk

    Steris Corporation is recalling 129 ATLAS Loading Cars because the latch may fail to engage when empty, causing the unit to slide or fall.

    Product
    ATLAS Loading Car
    Category
    Medical Device
    Distribution
    Distributed nationwide