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

25801–25825 of 27722

HighFDA (Devices)·Z-0422-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0261-2014·2013-11-27
Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.
Product
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0268-2014·2013-11-27
Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0267-2014·2013-11-27
Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
Product
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0349-2014·2013-11-27
Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling GemStar infusion pumps because pressure sensor calibration drift may cause the device to fail occlusion tests or report false errors.
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…
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-0265-2014·2013-11-27
Medtronic Vascular Recalls Attain Hybrid Guide Wires Due to Coating Defect
Medtronic Vascular is recalling 1,674 Attain Hybrid Guide Wires because the PTFE coating may delaminate and detach from the device.
Product
ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0262-2014·2013-11-27
Medtronic Zinger Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.
Product
Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0266-2014·2013-11-27
Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.
Product
COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0362-2014·2013-11-27
Ossur Fixed Offset Adapter Recalled for Fatigue Cracks and Separation Risk
Ossur North America Inc is voluntarily recalling 66 units of the A-642100 Fixed Offset Adapter because the component can develop fatigue cracks and separate completely during normal use.
Product
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the…
Category
Medical Device
Distribution
10 states
SevereFDA (Devices)·Z-0348-2014·2013-11-27
Candela Laser GentleLase Pro Recalled for Unintended Pulse Emission Risk
Candela Corporation is recalling 1,258 GentleLase Pro laser surgical instruments because they may emit an unintended single pulse before the trigger is pressed, posing an injury risk.
Product
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0370-2014·2013-11-27
FDA Recalls Medcare Max-500 Patient Lifts Due to Potential Load Failure
Ergosafe Products LLC is recalling 97 Medcare Max-500 patient stands because the lift might fail with the labeled 500-lb load rating.
Product
Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0264-2014·2013-11-27
Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0263-2014·2013-11-27
Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.
Product
THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0350-2014·2013-11-27
Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling 43,840 GemStar infusion pumps worldwide because pressure sensor calibration drift may cause the device to fail occlusion tests or issue false alarms.
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…
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-0352-2014·2013-11-27
Spacelabs recalls anesthesia workstation absorbers due to potential switch failure
Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.
Product
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2014·2013-11-27
Siemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1200 System Software versions 2.00 and 2.01 due to incorrect ration parameter flagging behavior.
Product
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2014·2013-11-27
Siemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1800 System Software V2.01 due to ration parameters flagging behavior issues.
Product
ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2014·2013-11-27
Synthes Soft Tissue Retractor Recalled for Potential Nut Breakage
Synthes USA HQ, Inc. is recalling 374 Soft Tissue Retractors because the locking screw nut may break if overtightened.
Product
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0373-2014·2013-11-27
GE Vivid E9 Ultrasound Systems Recalled for Software Lockup
GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.
Product
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0363-2014·2013-11-27
Stryker Rose Bed Siderail Latch Failure Recall
Stryker is recalling Model FL14E Rose Beds because siderails may appear latched when they are not, posing a risk of patient injury.
Product
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2014·2013-11-27
GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard
GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.
Product
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2014·2013-11-27
FDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk
Ergosafe Products LLC is recalling 233 Medcare Max-500 patient stands because the lift mechanism might fail under the labeled 500-lb load rating.
Product
Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2014·2013-11-27
Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard
Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.
Product
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce 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
HighFDA (Devices)·Z-0330-2014·2013-11-27
GE Centricity Laboratory Software Recalled for Panel Reflex Failure
GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2014·2013-11-27
Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure
Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.
Product
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

25801–25825 of 27722