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

33051–33075 of 40449

ModerateFDA (Devices)·Z-1645-2015·2015-06-03
Siemens SOMATOM Emotion 16 CT Scanner Software Recall
Siemens is recalling 75 SOMATOM Emotion 16 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1658-2015·2015-06-03
Siemens Immulite 2000 Water Bottle Recall for Quality Defects
Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.
Product
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1659-2015·2015-06-03
Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems
Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap from closing securely.
Product
Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1660-2015·2015-06-03
Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings
Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.
Product
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1644-2015·2015-06-03
Siemens SOMATOM Emotion 6 CT Scanner Software Recall
Siemens Medical Solutions is recalling 75 SOMATOM Emotion 6 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1663-2015·2015-06-03
Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings
Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.
Product
Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1662-2015·2015-06-03
Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies
Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.
Product
Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1667-2015·2015-06-03
Siemens Ysio Max Radiographic System Recalled for Software Data Loss
Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.
Product
SIEMENS Ysio Max; 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 and bariatric patients. It…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1666-2015·2015-06-03
United Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label
United Surgical Associates is recalling 756 Keo elastic wrist braces because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
Product
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1670-2015·2015-06-03
Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall
Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.
Product
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2015·2015-06-03
Siemens SOMATOM Perspective CT Scanner Software Recall
Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.
Product
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2015·2015-06-03
United Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label
United Surgical Associates is recalling 1,278 Elastic Ankle Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
Product
Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1682-2015·2015-06-03
Philips Ingenuity TF PET/MRI Recalled for Incorrect Chemical Shift Imaging Data
Philips Medical Systems is recalling 10 Ingenuity TF PET/MRI systems because the spectroscopy voxel map did not align with anatomical images, resulting in incorrect orientation of Chemical Shift Imaging data.
Product
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1685-2015·2015-06-03
Volk Optical Recalls 25D BIO Lenses Due to Incorrect Lot Number
Volk Optical Inc. is recalling six 25D Large Clear BIO Lenses because the incorrect lot number was engraved on the anodized aluminum ring.
Product
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1676-2015·2015-06-03
Biocare Medical Recalls D2-40 Lymphatic Marker Due to Incorrect Instructions
Biocare Medical is recalling 19 units of D2-40 Lymphatic Marker because incorrect Instructions for Use were shipped with the product.
Product
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1641-2015·2015-05-27
Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect
Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.
Product
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1643-2015·2015-05-27
Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation
Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.
Product
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1623-2015·2015-05-27
GE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts
GE Healthcare is recalling four CT scanners because over-torqued bolts could cause a component to detach, posing a risk of serious bodily injury.
Product
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1617-2015·2015-05-27
Medtronic Recalls Deep Brain Stimulation Extension Kits Due to Impedance Reports
Medtronic is recalling DBS Extension Kits (Models 37085 and 37086) after receiving reports of high impedances during implant procedures.
Product
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1631-2015·2015-05-27
Philips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error
Philips is recalling EPIQ 5 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations when using Metric settings.
Product
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2)…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1639-2015·2015-05-27
Richard Allan Scientific Recalls Mucolytic Agent Due to Fungal Contamination
Richard Allan Scientific is recalling Mucolytic Agent and Mucolexx after a customer complaint reported fungal contamination in two lots of Mucolexx.
Product
Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2015·2015-05-27
Baxter ABACUS Software Recalled for Potential TPN Formula Loading Errors
Baxter is recalling ABACUS SE and ME software because it may load incorrect total parenteral nutrition formulas when duplicate order numbers are used.
Product
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2015·2015-05-27
DeRoyal Specimen Retrieval Bags Recalled for Tearing During Use
DeRoyal Industries is recalling 5,359 Medium Specimen Retrieval Bags because they may tear or come apart during laparoscopic procedures.
Product
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1622-2015·2015-05-27
Roche Homocysteine Test System Recalled for Inaccurate Low Results
Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.
Product
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1629-2015·2015-05-27
Siemens IMMULITE TBG Test Kits Recalled for Inaccurate Results
Siemens Healthcare Diagnostics is recalling 155 IMMULITE TBG test kits because they may produce falsely low thyroid test results.
Product
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

33051–33075 of 40449