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 deaths or serious injuries are reported, 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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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

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551–575 of 582

  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1897-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1899-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1820-2013·2013-08-07

    DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk

    DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.

    Product
    LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
    Category
    Medical Device
    Distribution
    17 states
  • CriticalFDA (Devices)·Z-1770-2013·2013-07-31

    LeMaitre Recalls AlboGraft Vascular Grafts Due to Surface Bleeding

    LeMaitre Vascular is recalling 3 units of AlboGraft Woven with Collagen, Straight 30x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1756-2013·2013-07-31

    LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking

    LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.

    Product
    Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1761-2013·2013-07-31

    LeMaitre Vascular Recalls AlboGraft Vascular Grafts Due to Surface Leaking

    LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts because they may leak blood from the surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1787-2013·2013-07-31

    GE Healthcare Recalls Infinia Hawkeye 4 Gamma Cameras Due to Patient Death

    GE Healthcare is recalling Infinia Hawkeye 4 Nuclear Medicine Systems after a patient died from injuries sustained during a scan at a US VA Medical Center.

    Product
    GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1793-2013·2013-07-31

    GE Healthcare Recalls Optima NM/CT 640 Systems Due to Patient Death

    GE Healthcare is recalling 25 Optima NM/CT 640 systems worldwide after a patient died from injuries sustained during a scan on a related system.

    Product
    Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scannin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1790-2013·2013-07-31

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death

    GE Healthcare is recalling 13 Brivo NM615 nuclear medicine imaging systems worldwide after a patient died from injuries sustained during a scan on a related system.

    Product
    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1765-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage

    LeMaitre Vascular is recalling 2 units of AlboGraft Woven with Collagen, Straight 15x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1788-2013·2013-07-31

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death

    GE Healthcare is recalling Varicam/VG and VG Hawkeye devices after a patient died from injuries sustained during a scan at a US VA Medical Center.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by vario
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1791-2013·2013-07-31

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 108 Discovery NM 630 nuclear imaging systems worldwide due to a failure mode that can cause serious injury or death.

    Product
    Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1757-2013·2013-07-31

    LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage

    LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 18x09 due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1792-2013·2013-07-31

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death

    GE Healthcare is recalling 213 Discovery NM/CT 670 systems worldwide after a patient died from injuries sustained during a scan on a related system.

    Product
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1789-2013·2013-07-31

    GE Healthcare Recalls Elscint APEX Helix Gamma Cameras Due to Patient Death

    GE Healthcare is recalling 50 Elscint APEX Helix gamma cameras worldwide after a patient died from injuries sustained during a scan at a US VA Medical Center.

    Product
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of sc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1691-2013·2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1690-2013·2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1570-2013·2013-07-03

    Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery

    Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1456-2013·2013-06-12

    Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues

    Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.

    Product
    Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1462-2013·2013-06-12

    Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates

    Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.

    Product
    Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self conta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1274-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported death.

    Product
    Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.

    Product
    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1170-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide