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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30226–30250 of 40325

  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1583-2016·2016-05-04

    Mako Surgical Recalls RESTORIS PST RIO Offset Shell Impactor

    Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.

    Product
    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2016·2016-05-04

    Research Instruments Recalls Integra 3 Micromanipulators Due to Faulty Power Cable

    Research Instruments Ltd is recalling 380 Integra 3 micromanipulators because they were fitted with a potentially faulty power supply cable.

    Product
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

    Product
    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2016·2016-05-04

    GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect

    GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and ventilation.

    Product
    GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1559-2016·2016-05-04

    Becton Dickinson Recalls Listeria-Contaminated Trypticase Soy Agar Plates

    Becton Dickinson is recalling Trypticase Soy Agar and MacConkey II Agar plates contaminated with Listeria monocytogenes. The non-sterile media are used for growing and detecting bacteria.

    Product
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2016·2016-05-04

    3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error

    3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1558-2016·2016-05-04

    Siemens SOMATOM Force CT Systems Recalled for Image Artifacts

    Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.

    Product
    SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2016·2016-05-04

    Philips NeuViz 16 CT Scanner Recall for Patient Data Error

    Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.

    Product
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1585-2016·2016-05-04

    Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

    Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

    Product
    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2016·2016-05-04

    Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk

    Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion during use.

    Product
    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2016·2016-05-04

    Toshiba Recalls Aquilion Lightning CT System iStation Cover

    Toshiba American Medical Systems is recalling the Aquilion Lightning CT System iStation cover because it may fall off the gantry.

    Product
    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1556-2016·2016-05-04

    Stryker Recalls Spirit One Hospital Beds Due to Inaccurate Scale Systems

    Stryker is recalling 143 Spirit One A-C Powered Hospital Beds because their scale systems are inaccurate. The beds were distributed in 19 US states, Canada, and the UK.

    Product
    Spirit One A-C Powered Hospital Bed
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1528-2016·2016-05-04

    Corin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.

    Product
    Trinity Acetabular Shell Product Usage Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1565-2016·2016-05-04

    Baxter APD Cycler Recall for Incomplete Clinician Guide Instructions

    Baxter Healthcare is recalling 10 automated peritoneal dialysis cyclers because the clinician guide lacks instructions for priming the patient line.

    Product
    Automated peritoneal dialysis (APD) cycler
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1572-2016·2016-05-04

    Siemens ACUSON X700 Ultrasound System Recalled for Software Lockup

    Siemens is recalling four ACUSON X700 ultrasound systems due to a software error that causes the system to lock up, requiring a reboot to recover operation.

    Product
    ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1567-2016·2016-05-04

    Boston Scientific Recalls Mislabeled Ultraflex Tracheobronchial Stents

    Boston Scientific is recalling four Ultraflex Tracheobronchial stents because 10mm diameter units were mislabeled as 12mm diameter.

    Product
    Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2016·2016-05-04

    Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure

    Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.

    Product
    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1575-2016·2016-05-04

    Mindray Panorama Patient Monitoring Network Recalled for Date Reversion

    Mindray DS USA is recalling Panorama Patient Monitoring Network units that may revert to the year 2000 during Daylight Savings Time.

    Product
    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside…
    Category
    Medical Device
    Distribution
    Distributed nationwide