Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-12-21FDA-DeviceDeRoyal Industries IncClass IIDeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
- 2022-12-21FDA-DeviceNuVasive Specialized Orthopedics, Inc.Class IINUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 /
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, Vas Pack, Item No.888-2520,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Breast, Item No.693-276,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Angio Pack, Item No.686-199,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Vein, Item No.682-577,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Endo Pack, Item No.682-509,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIwww.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Medical Vein, Item No.682-330,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Vein, Item No.682-1732,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Phleb, Item No.682-1425,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, Lipo, Item No.681-254,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IISTRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, Labiaplasty PackItem No.570-3118,
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
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.
- 2022-12-21FDA-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
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.
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