TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Boston Scientific
Class I - Dangerous
Potential for leaks and loosening at the patient catheter connection
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
728333 Spectral CT 7500 -Computed Tomography X-ray system
Philips North America
Class I - Dangerous
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
728332 IQon Spectral CT-Computed Tomography X-ray system
Philips North America
Class I - Dangerous
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Delta Med SpA
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Philips North America
Class I - Dangerous
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Delta Med SpA
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Philips North America
Class I - Dangerous
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Teleflex Medical Europe
Class I - Dangerous
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Epimed International
Class I - Dangerous
Potential for stylet to protrude from the distal end of the catheter
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems
Class I - Dangerous
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
Class I - Dangerous
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Class I - Dangerous
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Delta Med SpA
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Delta Med SpA
Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Cytocell
Class I - Dangerous
May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Potential patient exposure to the graphite substrate.
Class I - Dangerous
Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.