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.

Agency

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

4601–4625 of 5111

SevereFDA (Devices)·Z-1989-2014·2014-07-09
GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.
Product
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose dia
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1978-2014·2014-07-09
Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.
Product
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1988-2014·2014-07-09
GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.
Product
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1985-2014·2014-07-09
Siemens Mobilett XP X-ray System Recalled for Fire Hazard
Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.
Product
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1815-2014·2014-07-02
Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2014·2014-07-02
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1812-2014·2014-07-02
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydro
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1822-2014·2014-07-02
Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket may be damaged during use.
Product
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and inter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1925-2014·2014-07-02
Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1854-2014·2014-07-02
NxStage Dialysate Sacks Recalled for Excess Aluminum Levels
NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.
Product
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1784-2014·2014-06-18
Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting
Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.
Product
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1733-2014·2014-06-18
Siemens Vista Air Compressor Recalled for Fire and Shock Hazards
Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.
Product
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnos
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1719-2014·2014-06-11
ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning
ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.
Product
MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1714-2014·2014-06-11
Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue
Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.
Product
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1715-2014·2014-06-11
Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation
Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.
Product
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-1706-2014·2014-06-11
GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps
GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.
Product
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1354-2014·2014-06-04
Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure
Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.
Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-1539-2014·2014-05-28
Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk
Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.
Product
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2014·2014-05-28
Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error
Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Ortho
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1645-2014·2014-05-28
Siemens 550 TxT Treatment Table Recalled for Calibration Loss
Siemens Medical Solutions is recalling 120 550 TxT Treatment Tables because they may lose calibration during treatment, posing a risk of patient mistreatment.
Product
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1638-2014·2014-05-28
Siemens MAMMOMAT Inspiration PC Monitor Holder Recall for Injury Risk
Siemens is recalling five MAMMOMAT Inspiration mammography units because the PC monitor holder can break, causing the monitor to fall and potentially injure users.
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-1634-2014·2014-05-28
Terumo Recalls CDI Blood Parameter Monitoring System for Inaccurate Readings
Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.
Product
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1628-2014·2014-05-28
Philips Recalls Lithium Ion Batteries for IntelliVue Patient Monitors
Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.
Product
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1636-2014·2014-05-28
Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error
Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.
Product
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1644-2014·2014-05-28
Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks
Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.
Product
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Category
Medical Device
Distribution
1 state

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4601–4625 of 5111