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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15226–15250 of 39988

  • HighFDA (Devices)·Z-0939-2021·2021-02-10

    Baxter Flow Coupler Monitor Recall Due to Battery Recharge Failure

    Baxter Healthcare is recalling 109 Flow Coupler Monitor devices because the battery may lose its ability to be recharged.

    Product
    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2021·2021-02-10

    Philips EPIQ Ultrasound Systems Recalled for Inaccurate Doppler Flow Visualization

    Philips is recalling EPIQ Diagnostic Ultrasound Systems because the Image Boost feature may cause inaccurate color and Doppler flow visualization when used with specific transducers.

    Product
    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only…
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0949-2021·2021-02-10

    Riverpoint Medical Recalls Velosorb Fast Sutures Due to Tensile Strength Defect

    Riverpoint Medical is recalling specific lots of Velosorb Fast sutures because a manufacturing error may cause inadequate tensile strength, potentially leading to suture break or wound dehiscence.

    Product
    Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0938-2021·2021-02-10

    Alung Technologies Recalls Hemolung Respiratory Assist System Infusion Pumps

    Alung Technologies is recalling 101 Hemolung Respiratory Assist System units due to potential delivery inaccuracy in the CME BodyGuard 323 infusion pump component.

    Product
    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2021·2021-02-10

    Topcon Harmony Referral System Recalled for Patient Data Mixing

    Topcon Medical Systems is recalling 13 Harmony Referral System units because software flaws allowed non-unique patient IDs to merge distinct patient records and images.

    Product
    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0947-2021·2021-02-10

    Philips EPIQ Ultrasound Systems Recalled for Control Panel Failure Risk

    Philips is recalling 12,080 EPIQ Diagnostic Ultrasound Systems because the control panel arm assembly may break off if subjected to undue force.

    Product
    Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2021·2021-02-10

    Brainreader Recalls Neuroreader Software Due to Database Discrepancy

    Brainreader ApS is recalling Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference database different from the FDA-cleared version.

    Product
    Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2021·2021-02-10

    Allergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions

    Allergan PLC is recalling Refresh Contacts Contact Lens Comfort Drops because the packages are missing the Instruction For Use insert. Consumers should stop using the product and contact the manufacturer.

    Product
    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0933-2021·2021-02-10

    Smith & Nephew Recalls Versabond AB Bone Cement Due to Heat Exposure

    Smith & Nephew is recalling 5,190 units of Versabond AB bone cement due to potential heat and humidity exposure that altered the product's consistency.

    Product
    VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2021·2021-02-10

    Fresenius Medical Care Recalls NaturaLyte Liquid Acid Concentrate Due to Missing Labels

    Fresenius Medical Care is recalling 2,280 cases of NaturaLyte Liquid Acid concentrate because bottles are missing product labels.

    Product
    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0940-2021·2021-02-10

    Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion

    Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.

    Product
    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number…
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0612-2020·2021-02-03

    Enztec Femoral Impactor Recall Due to Arm Fracture Risk

    Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.

    Product
    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0921-2021·2021-02-03

    OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts

    OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0922-2021·2021-02-03

    OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation

    OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0926-2021·2021-02-03

    Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function

    Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component failure mechanism that could cause loss of function.

    Product
    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0903-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues

    Respironics is recalling 934 V60 Ventilators worldwide due to potential navigation ring malfunctions and liquid ingress risks.

    Product
    Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 2,144 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2021·2021-02-03

    Boston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion

    Boston Scientific is recalling 7,093 Emblem S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.

    Product
    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0901-2021·2021-02-03

    Philips Respironics V680 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 3,453 V680 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide