Arrow International, Inc.
Also registered as Arrow International, LLC
United StatesFDA applicant, unverified
- Devices
- 22
- FDA recalls
- 70895 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Arrow International, Inc. makes
Arrow International, Inc. manufactures intravascular catheters, including pressure-injectable central venous catheters like the Arrow and ArrowG+ARD models, as well as peripherally inserted central catheters (PICCs) such as the CG+ Arrow PICC and Pressure Injectable PICC. The company also produces guidewires, including silicone-coated options, and intra-aortic balloon catheters like the UltraFlex and FiberOptix models. Additional products include chronic hemodialysis catheters, continuous nerve block catheters (e.g., FlexBlock and StimuCath), retrograde catheters (e.g., NextStep), and peripheral nerve block needles (e.g., UltraQuik).
These devices are classified under FDA Class II and are supported by 510(k) clearances. The portfolio is regulated under U.S. FDA requirements, with all listed products authorised for commercial distribution in the United States. The manufacturer is based in the United States.
Catalogue
Search and filter all 22 devicesFDA recalls
FDA recall records list 708 recalls initiated by Arrow International, Inc., the earliest on 2003-07-08 and the most recent on 2026-04-21. By recorded status: 97 ongoing and 611 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 141
- 2018 110
- 2019 66
- 2020 64
- 2021 10
- 2022 35
- 2023 7
- 2024 5
- 2025 0
- 2026 47
2026
- 21 Apr 2026 Z-2363-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2364-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2365-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2366-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2367-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2368-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2369-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2370-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2371-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2372-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2363-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Show the 25 most recent of 708 recalls
2026
- 21 Apr 2026 Z-2373-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2374-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2375-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2376-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2377-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2378-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2379-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2380-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2381-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2382-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2383-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2384-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2385-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2386-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2387-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Full distribution text
- 21 Apr 2026 Z-2373-2026 Class I Ongoing Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Frequently asked questions
How many devices does Arrow International, Inc. have in the registry?
The registry currently lists 22 devices for Arrow International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arrow International, Inc.'s devices?
Among its 22 most recently registered devices, Arrow International, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do Arrow International, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Arrow International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arrow International, Inc.?
FDA recall records list 708 recalls initiated by Arrow International, Inc., the most recent initiated on 2026-04-21. 97 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Arrow International, Inc. in the registry?
The most recently registered devices listed for Arrow International, Inc. include UltraFlex IAB, SILICONE COATED GUIDEWIRE, CG+ ARROW PICC POWERED BY ARROW VPS STYLET and ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.