CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Arrow Echogenic Introducer Needle recalled by Arrow International
Arrow International is recalling Arrow Echogenic Introducer Needle, distributed nationwide in the US. The recall was initiated on 11 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1910-2026
- FDA event ID
- 98618
- Recalling firm
- Arrow International, Morrisville, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +42 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Nationwide ArizonaCaliforniaGeorgiaMassachusettsMaineMichiganOregonPennsylvaniaVirginia
Questions about this recall
Why was it recalled?
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Which lots are affected?
Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347
Where was it sold?
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 98618This product is part of a recall event; the main page for the event is MAC" Two-Lumen Central Venous Access Kit for use recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MAC" Two-Lumen Central Venous Access Kit for use recalled | Arrow International | Other | Nationwide | |
| CLASS II | Arrow Radial Artery Catheterization Kit recalled by Arrow International | Arrow International | Other | Nationwide | |
| CLASS II | Arrow, Arrowg+ard And Arrowg+ard Blue Plus Pressure recalled | Arrow International | Other | Nationwide | |
| CLASS II | Flextip Plus Epidural Catheter;flexblock Continous recalled | Arrow International | Other | Nationwide | |
| CLASS II | Percutaneous Sheath Introducer with 7.5 -. Catheter recalled | Arrow International | Other | Nationwide | |
| CLASS II | Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit recalled | Arrow International | Other | Nationwide | |
| CLASS II | Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit recalled | Arrow International | Other | Nationwide |
More recalls from Arrow International
All 525| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Description/REF: Agba Picc G4 Stylet: 3L 6FR x 55CM recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: PI CVC KIT recalled by Arrow International | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |