🏥 Medical Devices Class I - Dangerous
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
All Recalls
95,018 total recalls in our database
BD Synapsys Informatics Solution, Catalog Number 444150
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
🏥 Medical Devices Class I - Dangerous
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
GE Healthcare Finland Oy
🏥 Medical Devices Class I - Dangerous
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
TEI Biosciences
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
TEI Biosciences
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
🏥 Medical Devices Class I - Dangerous
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
TEI Biosciences
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
TEI Biosciences
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
🏥 Medical Devices Class I - Dangerous
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
🏥 Medical Devices Class I - Dangerous
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
🏥 Medical Devices Class I - Dangerous
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
GE Healthcare Finland Oy
🏥 Medical Devices Class I - Dangerous
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).