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-DeviceStradis Medical, LLC dba Stradis HealthcareClass IIHENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
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, CUSTOM PK 2, Item No.570-3072
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, RHINO PACK, Item No.570-3070
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, Amnio Tray, Item No.570-3059,
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, EXTREMITY PACK, Item No.570-2946
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, CATH ANGIO PACK, Item No.570-2930
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, Knee Pack, Item No.570-2908,
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, PROCEDURE TRAY, Item No.570-2900,
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, LOOP RECORDER PACK, Item No.570-2891
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, BASIC EXTENDED PACK, Item No.570-2890
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, TEMP STIMULATOR SUPPLIES, Item No.570-2883
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, PACEMAKER PACK IItem No.570-2793
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, CATH PACK Item No.570-2789
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, UNIVERSAL TRAY, Item No.570-2787
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, MAJOR EXTREMITY PACK, Item No.570-2783,
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, OMFS, Item No.570-2779,
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, ENT SET UP PACK, Item No.570-2742
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, VEIN TRAY, Item No.570-2738,
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, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
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, ENT PACK, Item No.570-2718
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, GYN PACK, Item No.570-2625
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, BREAST PACK, Item No.570-2397
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, Basin Set, Item No.570-1803
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, Basin Pack, Item No.570-1692
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, PROCEDURE KIT, Item No.570-1508, general surgery tray
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, SURGICAL PAIN TRAY, Item No.570-1482
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, Novasure Pack, Item No.570-1462, general surgery tray
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, Vein Clinics 1, Item No.570-1426
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, Breast Augmentation tray, Item No.570-0611
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, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
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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