Stradis Healthcare
Complete recall history across all FDA and CPSC categories — 20 total recalls
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 (20)
FDA medical device enforcement actions by Stradis Healthcare
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 15, 2022 | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Tech... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs P... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy ... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | PICC KIT, 10/CS, ACCESS MEDICAL LABEL | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufacture... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. G... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Pac... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosp... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vi... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and ca... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per ba... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care T... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Heal... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| Dec 15, 2022 | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by ... | Potential for the outer bag having pinhole leaks near the seal, which may res... | Class II |
| May 10, 2022 | VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS | Potential for incomplete seals. | Class II |
| Apr 22, 2022 | Surgical Suture Kit | There is uncertainty about the integrity of the methods used to ensure the st... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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