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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32126–32150 of 40325

  • ModerateFDA (Devices)·Z-2733-2015·2015-09-09

    Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs

    Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.

    Product
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2725-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 3 mm Flow Probes due to a software defect that causes flow meters to display incorrect status messages.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2553-2015·2015-09-09

    Customed Universal Drainage Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2486-2015·2015-09-09

    FDA Recalls Bright Embrace Bili Light Due to Incorrect Temperature Labeling

    Physician Engineered Products, Inc. is recalling 97 Bright Embrace Single Bili Lights because the upper limit for ambient temperature was printed incorrectly in the instructions.

    Product
    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2724-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2729-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 6 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2726-2015·2015-09-09

    Transonic Flow Probe Recall Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2728-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.

    Product
    Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2727-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2015·2015-09-09

    Bayer Recalls Contour Next Control Solution for Potential Test Errors

    Bayer is recalling 5 million bottles of Contour Next Control Solution because improper shaking may cause inaccurate blood glucose meter readings.

    Product
    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2483-2015·2015-09-09

    Biomet Vision RingLoc Hip Prosthesis Recalled for Missing Screw Hole Plugs

    Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.

    Product
    Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2723-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error messages.

    Product
    Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2478-2015·2015-09-09

    Abbott FIRMap 60mm Catheter Recalled for Incorrect Expiration Date Labeling

    Abbott Electrophysiology is recalling 86 units of FIRMap 60mm Catheters because the expiration date was incorrectly printed on the labels.

    Product
    FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2374-2015·2015-09-02

    Ethicon Recalls SEDASYS Sedation Systems Due to Plastic Degradation

    Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.

    Product
    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2015·2015-09-02

    Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections

    Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.

    Product
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2462-2015·2015-09-02

    Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect

    Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.

    Product
    PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2015·2015-09-02

    Trilliant Surgical Reamer Heads Recalled for Guide Pin Fit Issues

    Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.

    Product
    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2015·2015-09-02

    Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error

    Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.

    Product
    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-2438-2015·2015-09-02

    Otto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure

    Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.

    Product
    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2447-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2015·2015-09-02

    GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss

    GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2015·2015-09-02

    Medline Recalls Central Line Kits Due to Incorrect Age Labeling

    Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.

    Product
    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2455-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide