Stradis Healthcare
Stradis Healthcare has 3 FDA enforcement events on this register (20 product records) between 2022 and 2022: 3 device; the busiest year was 2022 with 3.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in IL.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 15 Dec 2022 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile | Device | Class II | 18 | Ongoing |
| 10 May 2022 | VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS | Device | Class II | 1 | Ongoing |
| 22 Apr 2022 | Surgical Suture Kit | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Stradis Healthcare had?
3 enforcement events (20 product records) on this register, 2022–2022: 3 device.
Are any Stradis Healthcare recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Stradis Healthcare recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.