Extended Tip Applicator, 15 CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
All Recalls
95,018 total recalls in our database
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Becton Dickinson Infusion Therapy Systems
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Extended Tip Applicator, 8CM, Box of 5.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
🏥 Medical Devices Class I - Dangerous
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Jewel Precision Sheet Metal & Machining Co
🏥 Medical Devices Class I - Dangerous
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
Extended Tip Applicator 8CM, Box of 1.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
🏥 Medical Devices Class I - Dangerous
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Limacorporate S.p.A
🏥 Medical Devices Class I - Dangerous
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Becton Dickinson Infusion Therapy Systems
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
DxI 9000 Access Immunoassay Analyzer C11137
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Lack of sterility assurance.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
🏥 Medical Devices Class I - Dangerous
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures