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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16651–16675 of 27500

  • HighFDA (Devices)·Z-0207-2019·2018-10-31

    Howmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure

    Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.

    Product
    Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2019·2018-10-31

    Custom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0216-2019·2018-10-31

    Siemens StreamLab Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling StreamLab Refrigerated Storage Module 9000 units because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB - REFRIGERATED STORAGE MODULE 9000
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0250-2019·2018-10-31

    CHS Custom Convenience Kits Recalled for Sterility Compromise

    Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0212-2019·2018-10-31

    Siemens APTIO 15000 Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO 15000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO 15000 REFRIGERATED STORAGE MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0249-2019·2018-10-31

    Custom Healthcare Systems Recalls Vaginal Speculums Due to Sterility Compromise

    Custom Healthcare Systems is recalling vaginal speculums because incorrect sealing specifications compromised product sterility.

    Product
    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0215-2019·2018-10-31

    Siemens StreamLab Automation Modules Recalled for Missing Pacemaker Warning Label

    Siemens Healthcare Diagnostics is recalling 186 StreamLab Automation Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB CORE UNIT / LYNX WITH IOM
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0197-2019·2018-10-31

    Shimadzu TRINIAS Digital Angiographic System Recalled for C-Arm Movement Issue

    Shimadzu is recalling one TRINIAS Digital Angiographic System in Louisiana due to a software issue that may cause the C-arm to move unexpectedly, posing a risk of contact with patients or staff.

    Product
    TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0278-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0204-2019·2018-10-31

    ESAOTE MyLab Alpha Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE S.P.A. is recalling 10 MyLab Alpha Model 7400 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Alpha, Model 7400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2019·2018-10-31

    Ecolab Recalls Da Vinci Robotic System Disposable Accessory Kits

    Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.

    Product
    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2019·2018-10-31

    Custom Healthcare Systems Recalls 50 Curved Pean Forceps Kits

    Custom Healthcare Systems is recalling 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0553-2016·2018-10-31

    GE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk

    GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.

    Product
    GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0206-2019·2018-10-31

    ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Seven, Model 6400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2019·2018-10-31

    Canon MRI Systems Recall Due to SAR Display Error

    Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.

    Product
    Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0267-2019·2018-10-31

    CHS Custom Convenience Kits Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0245-2019·2018-10-31

    Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0232-2019·2018-10-31

    Ecolab Camera Arm Drapes Recalled for Potential Sterility Breach

    Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.

    Product
    Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap…
    Category
    Medical Device
    Distribution
    Distributed nationwide