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 deaths or serious injuries are reported, 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

4801–4825 of 5038

SevereFDA (Devices)·Z-1117-2013·2013-04-24
Hospira GemStar Infusion Pump Recall for Potential Over-Infusion
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much medication.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2013·2013-04-24
Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2013·2013-04-24
SR Instruments FG3105 Patient Scales Recalled Due to Load Cell Failures
SR Instruments is recalling 806 FG3105 patient scales used with Joerns Healthcare lifters after two load cell failures caused patient falls.
Product
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected betwe
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1052-2013·2013-04-24
Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues
Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.
Product
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2013·2013-04-24
Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift
Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.
Product
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1150-2013·2013-04-24
Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk
Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.
Product
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1058-2013·2013-04-17
Respironics Infant Masks Recalled Due to Incorrect Size Labeling
Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.
Product
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-1066-2013·2013-04-17
Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled
Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.
Product
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1078-2013·2013-04-17
GE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk
GE Healthcare is recalling Infinia Nuclear Medicine Systems because a mechanical defect could cause the detector to slide, posing a risk to patients and operators.
Product
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1081-2013·2013-04-17
Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error
Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.
Product
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult C
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1063-2013·2013-04-17
FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units
FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.
Product
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1051-2013·2013-04-17
GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors
GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.
Product
Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1045-2013·2013-04-10
Zimmer NexPosure Retractor Portals Recalled for Sterility Risk
Zimmer, Inc. is recalling 58 NexPosure retractor portals due to a potential breach in the sterile inner pouch, which could lead to product contamination and patient infection.
Product
Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0965-2013·2013-03-27
Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation
Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.
Product
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Category
Medical Device
Distribution
17 states
SevereFDA (Devices)·Z-0953-2013·2013-03-27
Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch
Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.
Product
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0971-2013·2013-03-27
DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk
DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.
Product
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0928-2013·2013-03-20
Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach
Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.
Product
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0939-2013·2013-03-20
Draeger Infinity Acute Care System Recall for Inaccurate Blood Pressure Readings
Draeger Medical is recalling 260 Infinity Acute Care System monitoring units because liquid ingress in the cable can cause inaccurate invasive blood pressure measurements.
Product
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0945-2013·2013-03-20
Philips CT Systems Recalled for Patient Table Brake Malfunction
Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.
Product
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction
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 lo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2013·2013-02-27
Hill-Rom Recalls Liko Overhead Rail Systems Due to Corrosion
Hill-Rom is recalling Liko Overhead Rail Systems because hardware corrosion in high-humidity areas caused two rail failures.
Product
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situ
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0849-2013·2013-02-27
Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling 266 units of NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0831-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Fracture Risk
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves due to a potential fracture risk at the taper junction during normal gait activities.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide

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4801–4825 of 5038