Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056
Covidien
Class I - Dangerous
Compromised sterility due to breach of barrier
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Compromised sterility due to breach of barrier
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Class I - Dangerous
Compromised sterility due to breach of barrier
Video Duodenoscope
Pentax Medical Company
Class I - Dangerous
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
MicroAire Surgical Instruments
Class I - Dangerous
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Class I - Dangerous
Compromised sterility due to breach of barrier
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Leica Microsystems
Class I - Dangerous
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Compromised sterility due to breach of barrier
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Covidien
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Compromised sterility due to breach of barrier
Class I - Dangerous
Compromised sterility due to breach of barrier
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Natus Medical Incorporated
Class I - Dangerous
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.