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

28851–28875 of 40357

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
ModerateFDA (Devices)·Z-0024-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0047-2017·2016-10-12
Toshiba Aquilion RXL CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion RXL CT scanners because a reconstruction error may interrupt scans if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2906-2016·2016-10-12
Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect
Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.
Product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2017·2016-10-12
Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0017-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Blue Dental Porcelain
Ivoclar Vivadent is recalling 79 units of Zenostar MT Color Impulse blue dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0032-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 13 units of Zenostar MT Color C3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0049-2017·2016-10-12
Toshiba Celesteion CT Scanner Recalled for Potential Reconstruction Errors
Toshiba is recalling 165 Celesteion CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0028-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B3 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 27 units of Zenostar MT Color B3 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0048-2017·2016-10-12
Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.
Product
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-0027-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2833-2016·2016-10-12
TriFoillmaging CT Scanners Recalled for X-Ray Compliance Issues
Northridge Tri-Modality Imaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners because they may not meet federal X-ray safety standards.
Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0026-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0035-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0036-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0033-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 10 units of Zenostar MT Color C4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0023-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 42 units of Zenostar MT Color A3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide

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