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

View all 93 device recalls →

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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