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

26201–26225 of 27722

SevereFDA (Devices)·Z-1966-2013·2013-08-21
Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach
Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.
Product
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1902-2013·2013-08-21
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 International Catalog Number: 45512 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1904-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.
Product
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product 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 be used…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1906-2013·2013-08-21
Nova Max Plus Monitor System Recalled for False High Glucose Readings
Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.
Product
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1901-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Product
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1903-2013·2013-08-21
Nova Max Plus Glucose Monitor Kits Recalled for False High Readings
Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.
Product
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1905-2013·2013-08-21
Nova Max Plus Monitor System Recalled for False High Glucose Readings
Nova Biomedical is recalling Nova Max Plus Monitor Systems because the test strips may produce false abnormally high glucose readings.
Product
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1957-2013·2013-08-21
SpineFrontier Invue Solid Driver Recalled Due to Broken Nipple
SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.
Product
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1898-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Product
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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
SevereFDA (Devices)·Z-1947-2013·2013-08-21
CareFusion Recalls Adult and Pediatric Manual Resuscitators Due to Oxygen Flow Blockage
CareFusion is recalling 14,112 manual resuscitators because a blocked oxygen connector may prevent supplemental oxygen from reaching the patient.
Product
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1963-2013·2013-08-21
Edwards Lifesciences Recalls Anastaflo Intravascular Shunts Due to Adhesive Concerns
Edwards Lifesciences is recalling specific lots of Anastaflo intravascular shunts because excessive adhesive on the shunt body may interfere with suturing during bypass graft construction.
Product
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1942-2013·2013-08-21
GE Healthcare Recalls Mobile X-Ray Units Due to Erratic Drive Performance
GE Healthcare is recalling Optima and Brivo mobile x-ray units because of erratic drive performance. The recall affects 458 units distributed worldwide.
Product
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2013·2013-08-21
Synthes Flexible Medullary Reamer Recalled Due to Cleaning and Corrosion Risks
Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.
Product
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1953-2013·2013-08-21
Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.
Product
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1959-2013·2013-08-21
GE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns
GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.
Product
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1943-2013·2013-08-21
GE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk
GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.
Product
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2013·2013-08-21
Veridex CellTracks Analyzer II Recalled for Patient Data Association Error
Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.
Product
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2013·2013-08-21
Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.
Product
REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2013·2013-08-21
Edwards Recalls EndoReturn Arterial Cannula Due to Component Error
Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.
Product
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2013·2013-08-21
Carestream DRX Evolution X-Ray System Recalled for Exposure Technique Change
Carestream Health is recalling DRX Evolution X-Ray systems due to a potential change in x-ray exposure technique.
Product
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2013·2013-08-21
GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues
GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.
Product
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2013·2013-08-21
Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues
Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.
Product
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2013·2013-08-21
Epocal BGEM Test Card Recall for Potential Glucose Measurement Errors
Epocal is recalling 828,750 BGEM Test Cards because the glucose sensor may report low results at high concentrations after 3-4 months of storage.
Product
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1949-2013·2013-08-21
Veridex CellTracks AutoPrep System Recalled for Patient Data Mismatch
Veridex is recalling CellTracks AutoPrep System software due to a reported error where patient demographics were incorrectly associated with another patient's ID.
Product
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2013·2013-08-21
Medtronic Navigation Recalls Framelink Software Version 5.4 for Measurement Discrepancies
Medtronic Navigation is correcting Framelink software version 5.4 due to potential discrepancies between exam images and displayed measurements during surgical planning.
Product
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Category
Medical Device
Distribution
0 states

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