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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21026–21050 of 27647

  • SevereFDA (Devices)·Z-2697-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2768-2016·2016-09-14

    Bayer Certegra Workstation Recalled for Fire and Smoke Risk

    Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.

    Product
    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Hyperbaric Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruptions.

    Product
    Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2016·2016-09-14

    Philips BrightView XCT Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2016·2016-09-14

    Smith & Nephew Whipknot Soft Tissue Cinch Suture Recalled for Sterility Breach

    Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because sterile packaging was breached, compromising sterility. The recall covers 34,065 units distributed worldwide.

    Product
    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2016·2016-09-14

    Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues

    Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.

    Product
    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pump Systems because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2016·2016-09-14

    Elekta Medical Linear Accelerator Recall for Loose Drive Gear Joint

    Elekta is recalling 553 Medical Linear Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Medical Linear Accelerator
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2749-2016·2016-09-14

    Boston Scientific Recalls Five Unapproved MRI Pacemakers

    Boston Scientific is recalling five implanted pacemakers that used an unapproved module configuration. The devices were shipped to customers in five states.

    Product
    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2730-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2750-2016·2016-09-14

    Hill-Rom Recalls 94 Affinity Four Birthing Beds Due to Defect

    Hill-Rom is voluntarily recalling 94 Affinity Four Birthing Beds (Model P3700) distributed in the US and abroad. The recall was initiated by the firm.

    Product
    Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping.…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2723-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Localization Systems Due to Tip Breakage

    Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2016·2016-09-14

    Philips BrightView X Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2016·2016-09-14

    GE Healthcare Recalls SIGNA Creator and Explorer MRI Devices

    GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI scanners due to an incorrect RF Power Monitor Function that could cause higher than expected thermal dose and localized heating to patients.

    Product
    GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2758-2016·2016-09-14

    Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

    Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

    Product
    e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2016·2016-09-14

    Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display

    Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.

    Product
    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2732-2016·2016-09-14

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2718-2016·2016-09-14

    ArjoHuntleigh Sara Combilizer Recalled for Potential Tipping Hazard

    ArjoHuntleigh is recalling 106 Sara Combilizer patient lifts due to a potential tipping hazard identified during internal testing. No adverse events or customer complaints have been reported to date.

    Product
    ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2733-2016·2016-09-14

    Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise

    Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.

    Product
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
    Category
    Medical Device
    Distribution
    Distributed nationwide