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

38826–38850 of 40449

SevereFDA (Devices)·Z-0892-2013·2013-03-13
Ad-Tech Macro Micro Subdural Electrodes Recalled for Sharp Edges
Ad-Tech Medical Instrument Corporation is recalling Macro Micro Subdural Electrodes because they may have sharp edges or fracture, posing a risk of injury to brain tissue.
Product
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2013·2013-03-13
Siemens ARTISTE syngo RT Therapist software recall for beam delivery error
Siemens is recalling 5 ARTISTE digital linear accelerators due to a software defect that may cause repeated delivery of radiation beams.
Product
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0901-2013·2013-03-13
GE Healthcare Recalls Advantage Workstation Volume Viewer Software
GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.
Product
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast…
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0908-2013·2013-03-13
Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges
Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.
Product
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2013·2013-03-13
Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns
Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.
Product
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0906-2013·2013-03-13
Philips CT System Software Recall for Incorrect Value Display
Philips is recalling 2,580 Extended Brilliance Workspace CT systems to fix a software defect that may display incorrect values.
Product
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer…
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-0902-2013·2013-03-13
Salyer Prn Biomedical Recalls Century Console Base Units
Salyer Prn Biomedical is recalling 9 Century Console Base units because the addition of a UPS Battery Backup did not comply with FDA premarket notification regulations.
Product
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0913-2013·2013-03-13
Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.
Product
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0914-2013·2013-03-13
Churchill Medical Recalls Lifeguard Infusion Sets Due to Labeling Error
Churchill Medical Systems is recalling 2,340 Lifeguard Infusion Sets because the labels incorrectly identify the needle gauge and item number.
Product
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0905-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin
Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0910-2013·2013-03-13
Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size
Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.
Product
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0912-2013·2013-03-13
Atricure Max1 Isolator Transpolar Pen Recalled for Incorrect Labeling
Atricure Inc. is recalling five Max1 Isolator Transpolar Pens due to incorrect Instructions for Use labeling.
Product
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0915-2013·2013-03-13
Steris Recalls Amsco Steam Sterilizers Due to Erroneous Alarm Activation
Steris Corporation is recalling Amsco C and Amsco 400 steam sterilizers because control board defects cause erroneous alarms that lock up the devices.
Product
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-0903-2013·2013-03-13
Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect
Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0909-2013·2013-03-13
Bard Access Systems Recalls Hickman and Leonard Catheters Due to Wrong Introducer Size
Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.
Product
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0900-2013·2013-03-13
Philips Digital Diagnost Radiographic System Recalled for Image Rotation Errors
Philips is recalling 360 Digital Diagnost systems because images may rotate in the wrong direction, causing electronic side markers to be misplaced.
Product
Philips Digital Diagnost Stationary radiographic system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0904-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues
Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.
Product
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0917-2013·2013-03-13
ConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology
ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.
Product
D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0916-2013·2013-03-13
Linvatec Recalls D3000 Advantage Drive Systems Due to Incorrect Panel Symbology
Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.
Product
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0911-2013·2013-03-13
BD Vacutainer Plus Plasma Separator Tubes Recalled for Deformed Reservoirs
Becton Dickinson is recalling BD Vacutainer Plus Plasma Separator Tubes due to deformed tube reservoirs reported in two customer complaints.
Product
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0887-2013·2013-03-06
Aesculap Bipolar Generator Foot Pedal Recalled for Energy Failure
Aesculap, Inc. is recalling 59 Bipolar Generator Foot Pedals because the bipolar energy did not stop after the pedal was released.
Product
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0896-2013·2013-03-06
Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk
Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.
Product
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2013·2013-03-06
Brio DBS implantable pulse generators recalled for unintended fluid ingress
Advanced Neuromodulation Systems Inc. is recalling Brio DBS System Model 6788 implantable pulse generators because unintended fluid ingress into the device header has been shown.
Product
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0897-2013·2013-03-06
Philips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk
Philips Medical Systems is recalling one Ingenuity TF PET/CT unit in Ohio because the system may not default to the correct gating trigger, posing a risk to patients.
Product
Ingenuity TF PET/CT. Diagnostic imaging system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0899-2013·2013-03-06
Philips MX 16-Slice CT Scanner Recall Due to Loose Table Screws
Philips Medical Systems is recalling 412 MX 16-Slice CT Scanner Systems because loose screws may cause the patient table top to detach.
Product
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Category
Medical Device
Distribution
18 states

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38826–38850 of 40449