🏥 Medical Devices Class I - Dangerous
Cather packaging may contain the incorrect French size.
All Recalls
95,102 total recalls in our database
Philips L12-4 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Servo-n Ventilator System. Model Number: 6694800.
Maquet Critical Care AB
🏥 Medical Devices Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Change Healthcare Cardiology Hemo Software
CHANGE HEALTHCARE CANADA COMPANY
🏥 Medical Devices Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
🏥 Medical Devices Class I - Dangerous
This device does not indicate for use in patients with respiratory failure.
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
🏥 Medical Devices Class I - Dangerous
Required inspections were not performed on finished product prior to release and distribution.
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Hardy Diagnostics
🏥 Medical Devices Class I - Dangerous
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Philips VL13-5 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips L8-4 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
Cather packaging may contain the incorrect French size.
Servo-u MR Ventilator System. Model Number: 6888800.
Maquet Critical Care AB
🏥 Medical Devices Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
🏥 Medical Devices Class I - Dangerous
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Philips L9-3 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.