Skip to content
RecallWatchMedical Device Safety
Manufacturer

Arrow International, LLC recalls

The FDA has posted 47 enforcement recalls from Arrow International, LLC since 2025, including 39 Class I (most serious) recalls. Most recent report: Jun 24, 2026.

Class I: 39Class II: 8
Class IOngoingZ-2366-2026

ARROW INTERNATIONAL, LLC recalls Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS

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 ster…

  • Cardiac Catheterization Kit
  • Nonconforming Material/Component
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IOngoingZ-2378-2026

ARROW INTERNATIONAL, LLC recalls Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC

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 ster…

  • Long-Term Greater Than 30 Days Therapeutic Intravascular Catheter
  • Nonconforming Material/Component
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IOngoingZ-2385-2026

ARROW INTERNATIONAL, LLC recalls Description/REF: ACCESS TRAY/GU-04020

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 ster…

  • Catheter Introducer
  • Nonconforming Material/Component
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IOngoingZ-2386-2026

ARROW INTERNATIONAL, LLC recalls Description/REF: PARACENTESIS KIT/ASK-00376-JHH

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 ster…

  • Disposable Surgical Instrument Kit
  • Nonconforming Material/Component
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IOngoingZ-2363-2026

ARROW INTERNATIONAL, LLC recalls PARACENTESIS KIT

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 ster…

  • Paracentesis Tray
  • Nonconforming Material/Component
ARROW INTERNATIONAL, L…NCJun 24, 2026

Firm name as filed with the FDA: “ARROW INTERNATIONAL, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.