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Stradis Medical, LLC dba Stradis Healthcare FDA Recalls
93 recalls on file across devices, 0 of them Class I and 92 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dentalClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Amnio Tray, Item No.570-3059,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, ENT PACK, Item No.570-2718Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Medical Vein, Item No.682-330,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSSClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSPClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Phleb, Item No.682-1425,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Vein Clinics 1, Item No.570-1426Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, CATH PACK Item No.570-2789Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Labiaplasty PackItem No.570-3118,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| Surgical room, Implant Pack, Item No.41111UTI, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dentalClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Knee Pack, Item No.570-2908,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, GYN PACK, Item No.570-2625Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Lipo, Item No.681-254,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dentalClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, BREAST PACK, Item No.570-2397Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Basin Pack, Item No.570-1692Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Basin Set, Item No.570-1803Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 2Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Vas Pack, Item No.888-2520,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, OMFS, Item No.570-2779,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascularClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Endo Pack, Item No.682-509,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Breast, Item No.693-276,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, VEIN TRAY, Item No.570-2738,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery trayClass IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, RHINO PACK, Item No.570-3070Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Vein, Item No.682-1732,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Vein, Item No.682-577,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, Angio Pack, Item No.686-199,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,Class IINov 2, 2022Medical and surgical procedure trays and kits underwent cert |
| NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697Class IIJul 25, 2022The sterile barrier may be compromised. |
| NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700Class IIJul 25, 2022The sterile barrier may be compromised. |
| NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701Class IIJul 25, 2022The sterile barrier may be compromised. |
| Surgicare Neuro Pack - Neurological KitClass IIFeb 25, 2022The outer bag may be perforated or torn, which may result in |
| Coryell Memorial Hosp Total, Joint Pack - Surgical KitClass IIFeb 25, 2022The outer bag may be perforated or torn, which may result in |
| Anterior Hip Pack - Surgical KitClass IIFeb 25, 2022The outer bag may be perforated or torn, which may result in |
| Total Knee Pack - Surgical KitClass IIFeb 25, 2022The outer bag may be perforated or torn, which may result in |
| Lum Lam Custom Pack - Anesthesia KitClass IIFeb 25, 2022The outer bag may be perforated or torn, which may result in |
| Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS BulkClass IIOct 28, 2021This recall has been initiated to address bulk packed, non-s |
| Standard IUD Insertion KitClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |
| Tenaculum, PlasticClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |
| Endometrial Biopsy KitClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |
| Foundation KitClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |
| IUD Insertion PackClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |
| IUD Insertion KitClass IISep 10, 2021Firm unable to confirm that the tenaculum devices were produ |