Stradis Medical recalls
Stradis Medical appears in 93 official U.S. recall notices indexed by RecallRadar, most recently on 2022-12-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 93 |
|---|---|
| Published | 2021-10-27 to 2022-12-21 |
| By agency | FDA Device (93) |
| By classification | Class II (93) |
| By status | ongoing (92), terminated (1) |
| Distribution named in notices | CO, CT, MA, MI, NC, NJ, NY, OH, OR, TX, US |
Recalls
- HENRY SCHEIN, Amnio Tray, Item No.570-3059
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Vein, Item No.682-1732
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, TEMP STIMULATOR SUPPLIES, Item No.570-2883
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, BASIC EXTENDED PACK, Item No.570-2890
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Vein Clinics 1, Item No.570-1426
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, PROCEDURE TRAY, Item No.570-2900
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Labiaplasty PackItem No.570-3118
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Angioplasty, Item No.682-1937
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, GYN PACK, Item No.570-2625
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Breast, Item No.693-276
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, CATH PACK Item No.570-2789
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Novasure Pack, Item No.570-1462, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Vas Pack, Item No.888-2520
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, MAJOR EXTREMITY PACK, Item No.570-2783
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, LOOP RECORDER PACK, Item No.570-2891
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, ENT SET UP PACK, Item No.570-2742
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, PACEMAKER PACK IItem No.570-2793
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, CATH ANGIO PACK, Item No.570-2930
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Basin Set, Item No.570-1803
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, PROCEDURE KIT, Item No.570-1508, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, EXTREMITY PACK, Item No.570-2946
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, SINGLE SHOT EPIDURAL, Item No.570-3089
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, CUSTOM PK 2, Item No.570-3072
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Vein, Item No.682-577
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Angio Pack, Item No.686-199
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Endo Pack, Item No.682-509
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Medical Vein, Item No.682-330
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, BREAST PACK, Item No.570-2397
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, UNIVERSAL TRAY, Item No.570-2787
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Phleb, Item No.682-1425
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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, Knee Pack, Item No.570-2908
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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. - STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical
Reason: 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.