ARROW INTERNATIONAL, LLC
ARROW INTERNATIONAL, LLC has 3 FDA enforcement events on this register (47 product records) between 2026 and 2026: 3 device; the busiest year was 2026 with 3.
67% of its events are Class I; the most common class is Class I (2). 3 events are listed as ongoing; the recalling firm's address is in NC.
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 |
|---|---|---|---|---|---|
| 21 Apr 2026 | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | Device | Class I | 35 | Ongoing |
| 10 Apr 2026 | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I | Device | Class I | 4 | Ongoing |
| 11 Mar 2026 | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks. | Device | Class II | 8 | Ongoing |
By type and class
Class I: 67% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has ARROW INTERNATIONAL, LLC had?
3 enforcement events (47 product records) on this register, 2026–2026: 3 device.
Are any ARROW INTERNATIONAL, LLC recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are ARROW INTERNATIONAL, LLC recalls?
2 Class I, 1 Class II. 67% 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.