🔍 RecallPedia

All Recalls

95,114 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,667
Consumer Products

Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).

American Medical Systems Innovation Center - Silicon Valley

🏥 Medical Devices Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Surgical Instruments Nationwide View Details →

GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.

Western / Scott Fetzer Company

🏥 Medical Devices Class I - Dangerous

The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.

Jan 31, 2015 Other Medical Devices View Details →

ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.

May 19, 2015 Diagnostic Equipment Nationwide View Details →

Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

Covidien

🏥 Medical Devices Class I - Dangerous

Devon Light Gloves contain splits or holes compromising the sterility

Apr 16, 2015 Surgical Instruments Nationwide View Details →

Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).

American Medical Systems Innovation Center - Silicon Valley

🏥 Medical Devices Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Surgical Instruments Nationwide View Details →

GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.

American Medical Systems Innovation Center - Silicon Valley

🏥 Medical Devices Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Diagnostic Equipment Nationwide View Details →

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Volcano

🏥 Medical Devices Class I - Dangerous

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Jun 22, 2015 Diagnostic Equipment Nationwide View Details →

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Volcano

🏥 Medical Devices Class I - Dangerous

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

Jun 22, 2015 Diagnostic Equipment Nationwide View Details →

GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Jul 1, 2015 Diagnostic Equipment Nationwide View Details →

Arctic Cat Prowler 500 HDX

Arctic Cat Inc., of Thief River Falls, Minn.

🏠 Consumer Products Class I - Dangerous

Fuel can leak from the fuel fitting at the throttle body, posing a fire hazard.

Jul 28, 2015 Other Consumer Products Nationwide View Details →

Diamond Sports face masks

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

Stitching on the face mask's harness can fail causing the mask to loosen or come off, posing a risk of impact injury.

Jul 28, 2015 Sports & Recreation Nationwide View Details →

Children's Animal-themed Sweaters

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The sweaters have a drawstring around the neck area that poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.

Jul 28, 2015 Children's Products Nationwide View Details →

Lawn and garden tillers

Husqvarna Consumer Outdoor Products N.A. Inc., of Charlotte, N.C.

🏠 Consumer Products Class III - Low Risk

The tiller's transmission shift rod and clip can come into contact with the control cable during shifting and cause the tiller to unintentionally move forward or backward, posing a risk of bodily injury and/or laceration.

Jul 23, 2015 Electronics Nationwide View Details →