💊 Drugs Class I - Dangerous
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
All Recalls
95,075 total recalls in our database
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 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: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 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.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE Medical Systems China Co.
🏥 Medical Devices Class I - Dangerous
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.
Spectral CT. Computed tomography X-ray system.
Philips North America
🏥 Medical Devices Class I - Dangerous
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
REF: 382544 BD Insyte Autoguard 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.
BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 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.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/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.
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, 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.
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
RECORDATI RARE DISEASES
🏥 Medical Devices Class I - Dangerous
Out of specification stability test result for the Caphosol B solution from process validation lots
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Jewel Precision Sheet Metal & Machining Co
🏥 Medical Devices Class I - Dangerous
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
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.
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.