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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

21076–21100 of 40339

  • ModerateFDA (Devices)·Z-1142-2019·2019-04-24

    Philips Brilliance 16 Air CT Systems Recalled for Collimator Defect

    Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.

    Product
    Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1195-2019·2019-04-24

    Siemens syngo Lab Data Manager System Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 449 syngo Lab Data Manager systems due to software issues. The recall covers systems distributed in the US and nine other countries.

    Product
    syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1170-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.

    Product
    Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1194-2019·2019-04-24

    Roche Albumin BCP Reagent Recalled for Calibration Failures and QC Imprecision

    Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.

    Product
    Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2019·2019-04-24

    Integra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1172-2019·2019-04-24

    Integra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling

    Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.

    Product
    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-1153-2019·2019-04-24

    Integra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error

    Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.

    Product
    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
    Category
    Medical Device
    Distribution
    26 states
  • LowFDA (Devices)·Z-1190-2019·2019-04-24

    Aniara Biophen LMWH Control C4 Recall for Incorrect Instructions

    Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.

    Product
    BIOPHEN LMWH Control C4, REF 224201
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1198-2019·2019-04-24

    Cordis Guiding Catheters Recalled for Frayed Mounting Card Fragments

    Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.

    Product
    Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2019·2019-04-17

    Encore Medical Recalls Exprt Precision System Hip Implant Components

    Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.

    Product
    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1100-2019·2019-04-17

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

    Product
    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2019·2019-04-17

    DePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments

    DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.

    Product
    CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2019·2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2019·2019-04-17

    LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria

    LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.

    Product
    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1122-2019·2019-04-17

    BD Blood Collection Assembly Recalled for Luer Breakage Risk

    Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.

    Product
    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1129-2019·2019-04-17

    DePuy CORAIL AMT High Offset Neck Segment Recall for Potential Debris

    DePuy Orthopaedics is recalling CORAIL AMT High Offset Neck Segments because debris or material may be found behind the O-rings.

    Product
    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2019·2019-04-17

    Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk

    Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.

    Product
    syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2019·2019-04-17

    Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2019·2019-04-17

    Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results

    Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2019·2019-04-17

    Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks

    Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.

    Product
    Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2019·2019-04-17

    Procept Biorobotics Recalls AquaBeam Handpieces Due to Potential Internal Leaks

    Procept Biorobotics is recalling 214 AquaBeam Handpieces because a micro-crack in a weld joint may cause an internal leak, potentially delaying or preventing the completion of medical procedures.

    Product
    AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2019·2019-04-17

    DePuy CORAIL Neck Trials Recalled for Potential Debris Behind O-rings

    DePuy Orthopaedics is recalling CORAIL AMT Standard Offset Neck Segments because debris or material may be found behind the O-rings. These surgical instruments are used in hip arthroplasty.

    Product
    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide