Arrow recalls

15 official recalls and safety alerts involving Arrow since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Arrow or the relevant agency.

  1. 2026-06-24
  2. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL, LLC recalls Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC 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…

    FDA · DeviceARROW INTERNATIONAL, LLCUS Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN,…Official notice →
  3. 2026-05-20
  4. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL, LLC recalls Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI,…

    16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance,…

    FDA · DeviceARROW INTERNATIONAL, LLCWorldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU,…Official notice →
  5. 2026-04-29
  6. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL, LLC recalls MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code:…

    Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    FDA · DeviceARROW INTERNATIONAL, LLCU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA,…Official notice →
  7. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is…

    Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured

    FDA · DeviceARROW INTERNATIONAL, LLCU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA,…Official notice →
  8. 2024-10-02
  9. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL Inc. recalls Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF…

    Reports have been received regarding open seals on the packaging.

    FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC,…Official notice →
  10. 2024-06-12
  11. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

    Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic…

    FDA · DeviceARROW INTERNATIONAL Inc.Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG,…Official notice →
  12. 2024-03-27
  13. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF…

    Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire…

    FDA · DeviceARROW INTERNATIONAL Inc.Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE,…Official notice →
  14. 2023-10-11
  15. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF…

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    FDA · DeviceARROW INTERNATIONAL Inc.USOfficial notice →
  16. 2023-09-27
  17. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution.Official notice →
  18. 2023-06-28
  19. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System

    Potential for catheter separation or leakage

    FDA · DeviceARROW INTERNATIONAL Inc.Nationwide distribution. International distribution to Canada.Official notice →
  20. 2022-12-21
  21. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

    There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

    FDA · DeviceARROW INTERNATIONAL Inc.WorldwideOfficial notice →
  22. US
    Drugs & medicalClass I

    ARROW INTERNATIONAL Inc. recalls Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d)…

    There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable…

    FDA · DeviceARROW INTERNATIONAL Inc.US Distributor in states of: FL, GA, KY, OH, PA and WV.Official notice →
  23. 2022-10-26
  24. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL Inc. recalls ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For…

    Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for…

    FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the state of Florida.Official notice →
  25. 2022-07-06
  26. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL Inc. recalls Arrow Three-Lumen CVC

    Gravity flow rates on the affected product lidstock are incorrect.

    FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the states of Florida.Official notice →
  27. 2021-11-24
  28. US
    Drugs & medicalClass I

    Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous…

    7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

    FDA · DeviceArrow International IncWorldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE…Official notice →