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

36951–36975 of 40325

ModerateFDA (Devices)·Z-0382-2014·2013-12-04
Southern Implants Recalls Tri-Nex Healing Abutments Due to Labeling Error
Southern Implants is recalling 197 Tri-Nex healing abutments because the packages were incorrectly labeled and contained the wrong product size.
Product
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0383-2014·2013-12-04
Thermo Fisher Recalls MAS Urinalysis Control Level 1 for Stability Failure
Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1 because the product failed to meet 30-day open vial stability specifications.
Product
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0428-2014·2013-12-04
3M Recalls Unitek Stainless Steel Crowns Due to Mislabeling
3M is recalling specific lots of Unitek Primary Stainless Steel Crowns because LL3 crowns were incorrectly labeled as UR4 crowns.
Product
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-0386-2014·2013-12-04
Lin-Zhi International Recalls Norbuprenorphine Urine Control Material
Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.
Product
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0407-2014·2013-12-04
Synthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling
Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.
Product
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0379-2014·2013-12-04
Alere Cholestech LDX Lipid Profile-GLU Test Cassettes Recalled for Labeling Error
Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.
Product
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched…
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

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36951–36975 of 40325