EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
All Recalls
95,114 total recalls in our database
10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
BIOPSYBELL S.R.L.
🏥 Medical Devices Class I - Dangerous
Products labeled as sterile were distributed, but may not have been sterilized.
🏥 Medical Devices Class I - Dangerous
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
🏥 Medical Devices Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.
🏥 Medical Devices Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
🏥 Medical Devices Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
🏥 Medical Devices Class I - Dangerous
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
🏥 Medical Devices Class I - Dangerous
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
🏥 Medical Devices Class I - Dangerous
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.