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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37326–37350 of 40449

  • HighFDA (Devices)·Z-0119-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating Risk

    Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.

    Product
    Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2014·2013-11-06

    bioMerieux Recalls chromID Salmonella Agar Due to Colony Color Issues

    bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.

    Product
    chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2014·2013-11-06

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Stimulation Issues

    Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2014·2013-11-06

    Xoran Mini CT Scanner Recalled for Dose Rate Specification Failures

    Xoran Technologies is recalling 320 Mini CT Scanners because they failed to meet internal specifications for dose rate, with complaints indicating rates both high and low.

    Product
    Xoran Mini CT Scanner
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2014·2013-11-06

    Breeze C Electric Scooter Recalled for Electrical Contact Fault

    S.A.E. Afikim is recalling 69 Breeze C electric scooters because an electrical contact may fail, potentially preventing the driver from stopping the vehicle.

    Product
    Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2014·2013-11-06

    Zimmer Recalls NexGen CR-Flex Tibial Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen CR-Flex Mobile Bearing Tibial Components because the packaging bags adhere to the device surfaces.

    Product
    NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2014·2013-11-06

    Fujinon Ultrasonic Endoscope Recall for Missing Set Screws

    Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.

    Product
    Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2014·2013-11-06

    Carestream DRX-Revolution Mobile X-ray System Recalled for Sparking Power Plug

    Carestream Health is recalling 180 DRX-Revolution Mobile X-ray Systems because the power plug generates sparks and becomes warm to the touch.

    Product
    Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Si Surgical Systems Due to Mounting Risk

    Intuitive Surgical is recalling 1,090 da Vinci Si Surgical Systems because improper restraints during transport could cause the monitor to become loose from its mount.

    Product
    da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2014·2013-11-06

    Stryker TPS Micro Driver Recalled for Silicone Potting Defect

    Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.

    Product
    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2014·2013-11-06

    Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating

    Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.

    Product
    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2014·2013-11-06

    Siemens Blood Gas Analyzers Recalled for Patient Identification Error Risk

    Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2014·2013-11-06

    Baxter Recalls Vented Spike Adapters Due to Potential Pouch Tears

    Baxter Healthcare is recalling 49,344 units of Vented Spike Adapters because potential tears in the pouch could compromise sterility.

    Product
    Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2014·2013-11-06

    Philips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk

    Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.

    Product
    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2014·2013-11-06

    Beckman Coulter LH 750 and LH 780 Hematology Analyzers Recalled for Valve Failure

    Beckman Coulter is recalling LH 750 and LH 780 hematology analyzers because check valves may fail, causing air or liquid leaks.

    Product
    COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0069-2014·2013-11-06

    Zimmer Recalls CPT Femoral Stems Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling CPT Femoral Stems because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    Product
    CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0082-2014·2013-11-06

    Maquet CARDIOHELP Base Unit Recalled for Display and Alarm Defects

    Maquet Medical Systems USA is recalling 63 CARDIOHELP Base Units because they may display error messages and have touch screens that turn black.

    Product
    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2014·2013-11-06

    Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen femoral components because the packaging bags adhere to the device surfaces.

    Product
    NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions

    Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.

    Product
    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2014·2013-11-06

    Integra Camino Intracranial Pressure Monitoring Catheters Recalled for Missing MR Safety Labeling

    Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.

    Product
    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2014·2013-11-06

    Zimmer Sidus Head Recall Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling Sidus Heads because the packaging bags adhere to the device surfaces. No units were distributed in the United States.

    Product
    Sidus" Head (Not distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2014·2013-11-06

    Xoran Minicat CT Scanners Recalled for Dose Rate Specification Failures

    Xoran Technologies is recalling 320 Minicat CT Scanners because they failed to meet specifications for dose rate. The devices were distributed worldwide and in the US.

    Product
    Xoran Minicat00202
    Category
    Medical Device
    Distribution
    Distributed nationwide