🏥 Medical Devices Class I - Dangerous
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
All Recalls
95,083 total recalls in our database
CS 100 Intra-Aortic Balloon Pump
Maquet Datascope Corp - Cardiac Assist Division
🏥 Medical Devices Class I - Dangerous
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
🏥 Medical Devices Class I - Dangerous
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
🏥 Medical Devices Class I - Dangerous
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Sorin Group USA
🏥 Medical Devices Class I - Dangerous
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Sorin Group USA
🏥 Medical Devices Class I - Dangerous
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
PerkinElmer Health Sciences
🏥 Medical Devices Class I - Dangerous
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Mini barrel charcoal grills
Bazhou Sanxin Steel, of China
🏠 Consumer Products Class I - Dangerous
The exterior paint on the grill can ignite, posing a fire hazard.
Children's two-piece woven pajama sets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Liquid glitter iPhone cases
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Liquid and glitter can leak out of the cases, causing skin irritation and burns to consumers.
Children's magnetic building sets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The building sets corner welds can break, allowing the panels and frames to separate and release magnets during play. When released, exposed magnets can create a choking hazard.
AccuPure floor-standing filtration dispensers
Water Solutions (Hong Kong) Limited of Hong Kong
🏠 Consumer Products Class I - Dangerous
The dispensers can overheat and smoke, posing fire and burn hazards.
Write Again® magnetic dry erase white boards
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The thin magnetic metal surface can separate from the product's wooden board, posing a laceration hazard.
A96555, PREDUST X2, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
🍎 Food Class I - Dangerous
Product may contain undeclared milk.
B4016W, 910277 Breader, NET WT 40 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
🍎 Food Class I - Dangerous
Product may contain undeclared milk.
B93756, BREADER X1@, NET WT 40 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
🍎 Food Class I - Dangerous
Product may contain undeclared milk.
B4AAF3, BREADER X1, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
🍎 Food Class I - Dangerous
Product may contain undeclared milk.
B2ADU3, BATTER MX X1*, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
🍎 Food Class I - Dangerous
Product may contain undeclared milk.