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

28826–28850 of 40357

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
ModerateFDA (Devices)·Z-0064-2017·2016-10-19
Winco TMM3 Video-Fluoroscopy Stretcher-Chair Recalled for Non-Conforming Component
Winco Mfg., LLC is recalling 264 TMM3 Series Video-Fluoroscopy Stretcher-Chairs because a non-conforming component caused the arms to no longer meet design specifications.
Product
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0065-2017·2016-10-19
Winco TMM4 Series Treatment Chair Recalled for Non-Conforming Component
Winco Mfg. is recalling 264 TMM4 Series Multi-Purpose Treatment Chairs because a non-conforming component caused the arms to no longer meet design specifications.
Product
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0083-2017·2016-10-19
Zimmer Biomet Recalls Phoenix Recon Soft Tissue Sleeve Guide Instruments
Zimmer Biomet is recalling 31 Phoenix Recon Soft Tissue Sleeve Guides due to incompatibility with new revision targeting arms, which may cause surgical delays.
Product
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0084-2017·2016-10-19
Zimmer Biomet Recalls Phoenix Recon Targeting Arm Surgical Instruments
Zimmer Biomet is recalling 31 Phoenix Recon Targeting Arm surgical instruments because old and new revisions are not interchangeable, potentially causing surgical delays.
Product
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0079-2017·2016-10-19
RaySearch Radiation Therapy Treatment Planning System Software Recall
RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.
Product
Radiation Therapy Treatment Planning System, Model 5.0
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0066-2017·2016-10-19
Winco TMM5 Mobile Surgical Stretcher-Chair Recalled for Design Non-Conformance
Winco Mfg. is recalling 264 TMM5 Series Mobile Surgical Stretcher-Chairs because non-conforming components caused the arms to no longer meet design specifications.
Product
TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0059-2017·2016-10-19
Teleflex Johans Grasper Recall Due to Labeling Error
Teleflex Medical is recalling 160 Johans Graspers because they were mislabeled as Gripper Graspers. The sterile surgical instruments were distributed to six US states.
Product
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0063-2017·2016-10-19
A&D Blood Pressure Monitors Recalled for Small Cuff Labeling Error
A&D Engineering is recalling 378 blood pressure monitors that were not labeled for use with small cuffs. The devices were distributed to distributors in New York, Massachusetts, Virginia, and Texas.
Product
Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0068-2017·2016-10-19
Surgical Specialties Recalls BioSentry Tract Sealant System Due to Packaging Defect
Surgical Specialties Mexico is recalling the BioSentry Tract Sealant System because the product packages may have open seals.
Product
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-0058-2017·2016-10-19
Teleflex Gripper Graspers Recalled for Labeling Error
Teleflex Medical is recalling 160 Gripper Graspers due to a labeling error where they were mislabeled as Johans Graspers.
Product
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-0057-2017·2016-10-19
Circulatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
Circulatory Technology Inc is recalling 958 units of Better-Bladder devices with 14-inch tubing due to twisted or wrinkled balloon components.
Product
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Category
Medical Device
Distribution
Distributed nationwide
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

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28826–28850 of 40357