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

20926–20950 of 27647

HighFDA (Devices)·Z-0078-2017·2016-10-19
TheraSphere Y-90 Microspheres Recalled for Incorrect Radioactivity Labeling
Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere Y-90 Glass Microspheres shipped to Hong Kong because the labeled radioactivity was incorrect.
Product
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0074-2017·2016-10-19
Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues
Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.
Product
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0075-2017·2016-10-19
Banyan Medical Pyramidal Tip Trocar Recalled for Sterility Concerns
Banyan Medical is recalling 5 x 55mm Pyramidal Tip Trocars due to a potential lack of assurance of sterility. The recall affects 64 boxes distributed in Indiana and Tennessee.
Product
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0007-2017·2016-10-12
Baxter Recalls 0.2 Micron Filters Due to Missing Membrane
Baxter Corporation is voluntarily recalling 0.2 Micron Filters because the filter membrane may be missing, allowing particulate matter to pass through.
Product
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0040-2017·2016-10-12
Trumpf Medical Systems Recalls TruSystem Mobile Operating Columns
Trumpf Medical Systems is recalling 84 TruSystem mobile operating columns because they may unexpectedly descend approximately 20 centimeters.
Product
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table…
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-2917-2016·2016-10-12
Cardinal Health Recalls Blue Impervious Gowns for Flammability Defect
Cardinal Health is recalling Blue Impervious Gowns, X-Large, because they failed to meet federal flammability standards for vinyl plastic film.
Product
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0015-2017·2016-10-12
Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk
Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
Product
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2017·2016-10-12
Argon Medical Devices Recalls MicroStic Plus Sheaths Due to Dilator Hub Defect
Argon Medical Devices is recalling 200 units of MicroStic Plus sheaths because the dilator hub is too small to secure the dilator to the sheath.
Product
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2908-2016·2016-10-12
Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.
Product
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0041-2017·2016-10-12
Trumpf Medical Systems Recalls Stationary Column TruSystem 7599 Operating Tables
Trumpf Medical Systems is recalling 84 Stationary Column TruSystem 7599 units because they may unexpectedly descend approximately 20 centimeters.
Product
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0043-2017·2016-10-12
Trumpf Medical Systems Recalls TruSystem Operating Tables Due to Unexpected Descent
Trumpf Medical Systems is recalling 84 TruSystem 7000 U operating tables because they may unexpectedly descend approximately 20 centimeters.
Product
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0042-2017·2016-10-12
Trumpf Medical Systems Recalls Floor Mounting Columns for Unexpected Descent
Trumpf Medical Systems is recalling 84 Floor Mounting Columns because they unexpectedly descended approximately 20 centimeters, posing a risk to patient safety during surgery.
Product
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0013-2017·2016-10-12
Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk
Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.
Product
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0038-2017·2016-10-12
RayStation Radiation Therapy Planning Software Recalled for Dose Calculation Errors
RaySearch is recalling RayStation software versions 2.5 through 5.0 due to dose calculation errors when using specific region of interest settings.
Product
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2905-2016·2016-10-12
Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.
Product
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2909-2016·2016-10-12
Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.
Product
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0039-2017·2016-10-12
Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.
Product
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2017·2016-10-12
Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect
Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
Product
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0008-2017·2016-10-12
Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue
Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.
Product
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0003-2017·2016-10-12
Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect
Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.
Product
Vanguard 360 Revision Knee System Knee prostheses
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0045-2017·2016-10-12
LDR Spine Recalls ROI-A Anterior Delivery Device Due to Binding
LDR Spine USA is recalling 24 units of the ROI-A Anterior Delivery Device because the T-handle rotation has experienced binding. No patient injuries have been reported.
Product
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0016-2017·2016-10-12
Panoramic PC-1000 X-ray Systems Recalled for Safety Nut Defect
Panoramic Rental Corp. is voluntarily correcting PC-1000 X-ray systems because a safety nut may be ineffective, posing a risk of blunt force trauma to the head, neck, or shoulders.
Product
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2783-2016·2016-10-05
Anspach Effort Recalls Light Adaptors for Small Battery Drive Devices
The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.
Product
Light Adaptor for Small Battery Drive and Small Battery Drive II.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2883-2016·2016-10-05
Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.
Product
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2880-2016·2016-10-05
Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings
Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.
Product
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
Category
Medical Device
Distribution
Distributed nationwide

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20926–20950 of 27647