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

26276–26300 of 27722

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
SevereFDA (Devices)·Z-1755-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling specific AlboGraft Vascular Grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 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-1764-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 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-1760-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 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-1763-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling two units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 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-1769-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leaking
LeMaitre Vascular is recalling two units of AlboGraft Woven with Collagen vascular grafts because blood may leak from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 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-1758-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking
LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 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-1759-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 20x10 (Lot 56890A) due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 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-1777-2013·2013-07-31
Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues
Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.
Product
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1797-2013·2013-07-31
Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.
Product
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life…
Category
Medical Device
Distribution
Distributed nationwide

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