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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39926–39950 of 40356

  • ModerateFDA (Devices)·Z-2247-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a corporate merger.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2012·2012-08-29

    GE OEC Fluoroscopes Recalled for Snubber Board Safety Standard Non-Compliance

    GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.

    Product
    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2222-2012·2012-08-29

    Conformis iTotal CR Knee Replacement System Recalled for Labeling Addendum

    Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.

    Product
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2261-2012·2012-08-29

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Gas Regulator Failure

    Galil Medical is recalling Visual-ICE Cryoablation Systems because gas regulators may fail, rendering the devices inoperable.

    Product
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2012·2012-08-29

    McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status

    McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.

    Product
    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2246-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2243-2012·2012-08-29

    Sunquest Encompass Software Recalled for Daylight Saving Time Time Display Error

    Sunquest Information Systems is recalling Encompass software versions 2.4 and later because specimen collection times display one hour late during Daylight Saving Time.

    Product
    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2227-2012·2012-08-29

    Beckman Coulter Access Total T3 Reagent Recalled for Negative Bias

    Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.

    Product
    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2062-2012·2012-08-22

    Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk

    Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.

    Product
    Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2061-2012·2012-08-22

    Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality

    Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.

    Product
    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2063-2012·2012-08-22

    Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.

    Product
    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2064-2012·2012-08-22

    Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.

    Product
    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2207-2012·2012-08-22

    Philips Essenta DR X-Ray System Recalled Due to Potential C-Arm Fall

    Philips Healthcare Inc. is recalling seven Essenta DR X-ray systems because the C-arm may fall. The recall covers units distributed in the US and several international countries.

    Product
    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2174-2012·2012-08-22

    Shiley Reusable Tracheostomy Tubes Recalled Due to Cannula Connection Issues

    Nellcor Puritan Bennett Inc. is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes due to consumer complaints regarding the connections and functions of the inner and outer cannula.

    Product
    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2206-2012·2012-08-22

    Synthes Hemostatic Bone Putty Recalled for Potential Ignition Risk

    Synthes USA HQ, Inc. is recalling 8,853 packs of Hemostatic Bone Putty because the product may ignite if contacted with electrosurgical cautery systems during surgery.

    Product
    Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-2208-2012·2012-08-22

    Philips Easy Diagnost Classic x-ray system recall for switch defect

    Philips Healthcare Inc. is recalling 12 Easy Diagnost Classic stationary x-ray systems because an incorrectly mounted inclination switch may fail to stop table tilting.

    Product
    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2185-2012·2012-08-22

    CareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls

    CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.

    Product
    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2012·2012-08-22

    GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements

    GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.

    Product
    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units made of 455 stainless steel.

    Product
    Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.

    Product
    00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2012·2012-08-22

    Zimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.

    Product
    00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide