DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
All Recalls
95,018 total recalls in our database
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
GEO-MED CATARACT PACK, REF 89-5790.08
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal TLIF PACK, REF 89-8780.04
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
DeRoyal ACDF PACK, REF 89-8779.03
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal PODIATRY PACK, REF 89-8359.13
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal FOOT PACK, REF 89-9252.07
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
STRADIS HEALTHCARE, Breast, Item No.693-276,
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.