Stradis Medical, LLC dba Stradis Healthcare
Complete recall history across all FDA and CPSC categories — 93 total recalls
Stradis Medical, LLC dba Stradis Healthcare appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (93)
FDA medical device enforcement actions by Stradis Medical, LLC dba Stradis Healthcare. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 2, 2022 | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery ... | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, GYN PACK, Item No.570-2625 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, ENT PACK, Item No.570-2718 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Basin Pack, Item No.570-1692 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Medical Vein, Item No.682-330, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery ... | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Breast, Item No.693-276, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Knee Pack, Item No.570-2908, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Amnio Tray, Item No.570-3059, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, RHINO PACK, Item No.570-3070 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Vein Clinics 1, Item No.570-1426 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Lipo, Item No.681-254, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Angio Pack, Item No.686-199, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, VEIN TRAY, Item No.570-2738, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein, Item No.682-577, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein, Item No.682-1732, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, OMFS, Item No.570-2779, | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
| Nov 2, 2022 | HENRY SCHEIN, CATH PACK Item No.570-2789 | Medical and surgical procedure trays and kits underwent certain manufacturing... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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