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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Minimum severity

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

Clear filters

30726–30750 of 40325

  • HighFDA (Devices)·Z-1065-2016·2016-03-16

    Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue

    Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.

    Product
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2016·2016-03-16

    Sedecal Mobile X-ray Systems Recalled for Uncommanded Movements

    Sedecal S.A. is recalling 349 mobile X-ray systems because static electricity and other issues can cause uncommanded movements.

    Product
    Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2016·2016-03-16

    Arrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage

    Arrow International Inc. is recalling Super Arrow-Flex Percutaneous Sheath Introducer Sets because packaging damage may compromise sterility, posing a potential infection risk.

    Product
    Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: ***…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2016·2016-03-16

    Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2016·2016-03-16

    Biomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk

    Biomet is recalling 21,268 Crosslock DVR ePAK surgical sets because components may oxidize during storage. This could cause an inflammatory reaction if material enters the surgical wound.

    Product
    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2016·2016-03-16

    Spacelabs Xhibit Central Station Recalled for Height and Weight Input Error

    Spacelabs Healthcare is recalling Xhibit Central Station units because patient height and weight values may be switched, causing incorrect Body Surface Area calculations.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1080-2016·2016-03-16

    FDA Recalls Custom Tubing Extensions Due to Potential Cracking

    Value Plastics is recalling 33,000 custom tubing extensions because the parts may crack. The devices were distributed to three consignees in New York, Pennsylvania, and Minnesota.

    Product
    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1077-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 because they show bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2016·2016-03-16

    Ortho-Clinical VITROS 350 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to increased error codes when using specific calibrators.

    Product
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2016·2016-03-16

    Verathon Recalls BladderScan and AortaScan Devices for Manual Clarification

    Verathon is updating manuals for BladderScan and AortaScan devices to clarify they are not for diagnosing abdominal aortic aneurysms.

    Product
    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 due to bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2016·2016-03-16

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems and Strips

    Beckman Coulter is recalling iChem VELOCITY urine chemistry systems and strips because loose or missing analyte pads may go undetected by the system.

    Product
    iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1046-2016·2016-03-16

    Zimmer Biomet Recalls M/L Taper Hip Prosthesis Due to Etching Error

    Zimmer Biomet is recalling a specific lot of M/L Taper Hip Prostheses because the device was incorrectly etched as 'STD' instead of 'EXT', although the packaging is correct.

    Product
    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1074-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to increased error codes when using a specific calibrator kit.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E packs due to bias in the testosterone assay. The recall covers 519 packs distributed worldwide.

    Product
    Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 522 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1090-2016·2016-03-16

    TEM Systems Recalls ROTROL P Control for Thromboelastometry System

    TEM Systems Inc is recalling ROTROL P Control quality control material due to customer complaints about failed target ranges for alpha angle.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1089-2016·2016-03-16

    CMP Industries Recalls Impak Acrylic Resin Liquid Due to Potential Rust

    CMP Industries is recalling Impak Acrylic Resin Liquid, Lot 103113, due to potential rust discovered during an FDA inspection.

    Product
    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1088-2016·2016-03-16

    Medtronic O-arm O2 Imaging System Recalled for Loose Detector Panel Screws

    Medtronic is recalling one O-arm O2 Imaging System unit in Austria because loose screws may cause the detector panel to contact other parts, leading to noise, vibration, and poor image quality.

    Product
    Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 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 from 2D and 3D information of anatomic structures and objects…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1073-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Error Codes

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because they may generate specific error codes when used with a recalled Calibrator Kit 9 lot.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2016·2016-03-16

    Philips Allura Xper X-Ray Systems Recalled for Fluoroscopy Failure

    Philips is recalling 196 Allura Xper X-ray systems because they may display a 'Fluoro failed' error message when initiating fluoroscopy.

    Product
    Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2016·2016-03-16

    Ormco Recalls TF Adaptive Gutta Percha Points Due to Labeling Error

    Ormco is recalling TF Adaptive Gutta Percha Points because the inner label is misidentified as ML3, though the outer package correctly identifies the product as SM3.

    Product
    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1071-2016·2016-03-16

    Ortho-Clinical VITROS 250 Chemistry Systems Recalled for Condition Code Errors

    Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems due to increased U90-382 or 6LU condition codes generated when using Calibrator Kit 9, Lot 954.

    Product
    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2016·2016-03-16

    CooperSurgical Recalls Milex Arcing Diaphragms Due to Incorrect Size

    CooperSurgical, Inc. is recalling two units of Milex Arcing Diaphragms (Model MXWS95) because they contain an incorrect size diaphragm.

    Product
    Milex Arcing Diaphragm Size 95; Model Number: MXWS95
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1093-2016·2016-03-16

    Biomet Recalls Verso Shoulder Forked Retractors Due to Material Nonconformance

    Biomet is recalling Verso Shoulder Forked Retractors because they were manufactured with 420 stainless steel instead of the specified 420 S29 material.

    Product
    Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder…
    Category
    Medical Device
    Distribution
    31 states