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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14176–14200 of 27471

  • HighFDA (Devices)·Z-1143-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1329-2020·2020-02-26

    Philips CombiDiagnost PCF X-ray System Software Recall

    Philips is recalling 131 CombiDiagnost PCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1282-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects

    Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2020·2020-02-26

    Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0948-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.

    Product
    Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1341-2020·2020-02-26

    Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring

    Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.

    Product
    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1233-2020·2020-02-26

    Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.

    Product
    Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2020·2020-02-26

    Philips HeartStart FRx AED Recalled for Quality Standards Violation

    Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.

    Product
    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1274-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2020·2020-02-26

    Cardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns

    Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile. This could increase the risk of surgical site infections.

    Product
    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2020·2020-02-26

    Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift

    Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.

    Product
    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2020·2020-02-26

    Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.

    Product
    Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2020·2020-02-26

    Philips CombiDiagnost GCF X-ray System Software Recall

    Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2020·2020-02-26

    Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.

    Product
    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2020·2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1275-2020·2020-02-26

    Polysorb Suture Recall Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2020·2020-02-26

    Nobel Biocare Recalls Tapered Drills Due to Sterility Concerns

    Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide