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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35801–35825 of 40449

  • ModerateFDA (Devices)·Z-1666-2014·2014-06-04

    B. Braun Recalls Sprotte Spinal Needles Missing Introducer Needles

    B. Braun Medical is recalling 24-gauge Sprotte Spinal Needles and Trays because the accompanying introducer needles are missing.

    Product
    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1655-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1656-2014·2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1665-2014·2014-06-04

    GE Healthcare Recalls Centricity PACS Workstation Due to Image Rejection Error

    GE Healthcare is recalling 297 Centricity PACS Workstations because a software defect may cause images from previously displayed studies to be rejected unintentionally.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2014·2014-06-04

    Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference

    Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2014·2014-06-04

    Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference

    Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction

    Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2014·2014-06-04

    AGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect

    AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.

    Product
    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1653-2014·2014-06-04

    Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1667-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors

    Siemens is recalling 257 ACUSON SC2000 ultrasound systems due to software issues that may cause incorrect color flow data display and Doppler waveform failures.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
    Category
    Medical Device
    Distribution
    30 states
  • LowFDA (Devices)·Z-1663-2014·2014-06-04

    Siemens Recalls MAGNETOM Aera Systems Due to Missing Operator Manuals

    Siemens is recalling five MAGNETOM Aera magnetic resonance systems because a processing error may have prevented some users from receiving their Operator Manuals.

    Product
    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or…
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-1539-2014·2014-05-28

    Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk

    Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.

    Product
    Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2014·2014-05-28

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1523-2014·2014-05-28

    Maquet Datascope Intra-Aortic Balloon Pump Recall for Fan Assembly Failure

    Maquet Datascope is recalling 11,881 Intra-Aortic Balloon Pump units worldwide due to a potential fan assembly failure that could cause the power supply to overheat and shut down without warning.

    Product
    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2014·2014-05-28

    Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc.…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1645-2014·2014-05-28

    Siemens 550 TxT Treatment Table Recalled for Calibration Loss

    Siemens Medical Solutions is recalling 120 550 TxT Treatment Tables because they may lose calibration during treatment, posing a risk of patient mistreatment.

    Product
    550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2014·2014-05-28

    Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.

    Product
    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1634-2014·2014-05-28

    Terumo Recalls CDI Blood Parameter Monitoring System for Inaccurate Readings

    Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.

    Product
    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1628-2014·2014-05-28

    Philips Recalls Lithium Ion Batteries for IntelliVue Patient Monitors

    Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.

    Product
    Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1638-2014·2014-05-28

    Siemens MAMMOMAT Inspiration PC Monitor Holder Recall for Injury Risk

    Siemens is recalling five MAMMOMAT Inspiration mammography units because the PC monitor holder can break, causing the monitor to fall and potentially injure users.

    Product
    MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1639-2014·2014-05-28

    Fresenius Recalls Naturalyte Liquid Bicarbonate Concentrate Due to Contamination

    Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate bottles due to potential contamination. The product is used in hemodialysis machines.

    Product
    Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2014·2014-05-28

    Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

    Product
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1624-2014·2014-05-28

    Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

    Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2014·2014-05-28

    Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

    Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2014·2014-05-28

    GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings

    GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.

    Product
    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
    Category
    Medical Device
    Distribution
    Distributed nationwide