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

19251–19275 of 27647

HighFDA (Devices)·Z-3026-2017·2017-08-23
GE Medical Systems Recalls MRI Scanners Due to Power Supply Wiring
GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3021-2017·2017-08-23
GE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring
GE Medical Systems is recalling 68 Brivo MR355 and Optima MR360 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.
Product
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3024-2017·2017-08-23
GE Optima MR450w 1.5T MRI Scanner Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Optima MR450w 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3027-2017·2017-08-23
GE Signa MRI Systems Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Signa MRI systems due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3031-2017·2017-08-23
ICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.
Product
Plum 360 Infusion System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3018-2017·2017-08-23
Exactech Recalls Truliant Tibial Trial Handles Due to Pin Disassociation Risk
Exactech is recalling 68 Truliant Tibial Trial Handles because the pin may disassociate from the main body. The devices were distributed to 11 states.
Product
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-3042-2017·2017-08-23
C.R. Bard Recalls Arctic Sun 5000 Temperature Management Systems
C.R. Bard is recalling 3,450 Arctic Sun 5000 Temperature Management Systems due to potential failure if used for more than 2,000 hours without preventive maintenance.
Product
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3035-2017·2017-08-23
Magellan LeadCare II Blood Lead Test Kit Recall for Out-of-Range Controls
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because the lead controls were out of range. The recall affects 12,931 kits distributed worldwide.
Product
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3029-2017·2017-08-23
GE Medical Systems Recalls Signa PET/MR Systems Due to Shock Hazard
GE Medical Systems is recalling 68 Signa PET/MR systems because possible incorrect wiring of the Uninterruptable Power Supply could contribute to a potential shock hazard.
Product
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3040-2017·2017-08-23
Baxter HomeChoice Automated PD System Recalled for Air Delivery Risk
Baxter is recalling HomeChoice Automated PD systems because damaged cassettes may allow the device to deliver air to patients.
Product
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3023-2017·2017-08-23
GE Optima MR750 MRI Scanner Recalled for Potential Shock Hazard
GE Medical Systems is recalling 68 Optima MR750 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.
Product
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3033-2017·2017-08-23
Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
Cenorin, LLC is recalling 43 ThermaSure Series 300 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.
Product
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3020-2017·2017-08-23
Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
Cyberonics is recalling 1,909 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause them to lose battery life faster than expected.
Product
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2099-2017·2017-08-16
Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts
Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.
Product
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2871-2017·2017-08-16
Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.
Product
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2832-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2897-2017·2017-08-16
Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Set Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2872-2017·2017-08-16
C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach
C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.
Product
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2810-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.
Product
Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2821-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2910-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.
Product
PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2812-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2898-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2813-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2779-2017·2017-08-09
Myelotec Video Guided Catheters Recalled for Defective Access Port Body
Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.
Product
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Category
Medical Device
Distribution
5 states

How to read this listing

Filters

19251–19275 of 27647