NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Delta Med SpA
🏥 Medical Devices Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
All Recalls
95,114 total recalls in our database
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Philips North America
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
🏥 Medical Devices Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
🏥 Medical Devices 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.
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Hitachi Healthcare Americas
🏥 Medical Devices Class I - Dangerous
The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Epimed International
🏥 Medical Devices Class I - Dangerous
Potential for stylet to protrude from the distal end of the catheter
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Teleflex Medical Europe
🏥 Medical Devices Class I - Dangerous
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.