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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

26226–26250 of 27686

HighFDA (Devices)·Z-1847-2013·2013-08-07
Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
Product
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1848-2013·2013-08-07
Siemens Luminos dRF Fluoroscopic X-Ray System Recalled for Software Error
Siemens is recalling four Luminos dRF Fluoroscopic X-Ray systems due to a software error that may cause the table to tilt and collide with the floor.
Product
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1837-2013·2013-08-07
Omnicycle Elite Medical Exercise Equipment Recalled for Firmware Anomaly
Accelerated Care Plus is recalling 1,001 Omnicycle Elite units due to a firmware anomaly that may cause the equipment to operate at an incorrect speed in reverse mode.
Product
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2013·2013-08-07
Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size during surgery.
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1817-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk
Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.
Product
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1832-2013·2013-08-07
Exactech Articulated Driver Recalled for Potential Disassembly During Use
Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.
Product
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1818-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk
Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.
Product
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1836-2013·2013-08-07
St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
Product
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2013·2013-08-07
Heartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk
HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1869-2013·2013-08-07
SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.
Product
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of…
Category
Medical Device
Distribution
4 states
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-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…
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…
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-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-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-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…
Category
Medical Device
Distribution
Distributed nationwide
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-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…
Category
Medical Device
Distribution
Distributed nationwide
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-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…
Category
Medical Device
Distribution
Distributed nationwide
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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1766-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Blood Leakage
LeMaitre Vascular is recalling AlboGraft Woven with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1767-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood blushing or leaking from the surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1754-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling specific AlboGraft vascular grafts because blood may blush or leak from the surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state

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26226–26250 of 27686