ProductGuru Recalls

Brand

ARROW INTERNATIONAL, LLC: official recall notices

42 official recall or safety notices on this site name ARROW INTERNATIONAL, LLC, dated between 2024-04-29 and 2026-04-21. They were issued by 1 authority: US FDA — Medical Devices (42).

Countries where the notices were issued: United States (42).

Name as written in the notices: ARROW INTERNATIONAL, LLC; ARROW INTERNATIONAL Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

Notices by year

YearNotices
202639
20243

Notices by authority

AuthorityNotices
US FDA — Medical Devices42

All notices

DateAuthorityProductHazard (as classified)
2026-04-21US FDA — Medical DevicesDescription/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; AGB—
2026-04-21US FDA — Medical DevicesDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EP—
2026-04-21US FDA — Medical DevicesDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT—
2026-04-21US FDA — Medical DevicesDescription/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN—
2026-04-21US FDA — Medical DevicesDescription/REF: PARACENTESIS KIT/ASK-00376-JHH—
2026-04-21US FDA — Medical DevicesDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRA—
2026-04-21US FDA — Medical DevicesDescription/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS—
2026-04-21US FDA — Medical DevicesDescription/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC—
2026-04-21US FDA — Medical DevicesDescription/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-127—
2026-04-21US FDA — Medical DevicesDescription/REF: ACCESS TRAY/ASK-04001-MC3—
2026-04-21US FDA — Medical DevicesDescription/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: S—
2026-04-21US FDA — Medical DevicesDescription/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L—
2026-04-21US FDA — Medical DevicesDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090—
2026-04-21US FDA — Medical DevicesDescription/REF: PICC ACCESS TRAY/ASK-04001-CG1—
2026-04-21US FDA — Medical DevicesDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM—
2026-04-21US FDA — Medical DevicesDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A—
2026-04-21US FDA — Medical DevicesDescription/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; A—
2026-04-21US FDA — Medical DevicesDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F—
2026-04-21US FDA — Medical DevicesDescription/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000—
2026-04-21US FDA — Medical DevicesDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-L—
2026-04-21US FDA — Medical DevicesDescription/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU—
2026-04-21US FDA — Medical DevicesDescription/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER—
2026-04-21US FDA — Medical DevicesDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-—
2026-04-21US FDA — Medical DevicesDescription/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU—
2026-04-21US FDA — Medical DevicesDescription/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/A—
2026-04-21US FDA — Medical DevicesDescription/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-0471—
2026-04-21US FDA — Medical DevicesDescription/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE K—
2026-04-21US FDA — Medical DevicesDescription/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4;—
2026-04-21US FDA — Medical DevicesDescription/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T,—
2026-04-21US FDA — Medical DevicesPARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU—
2026-04-21US FDA — Medical DevicesDescription/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-—
2026-04-21US FDA — Medical DevicesDescription/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DE—
2026-04-21US FDA — Medical DevicesDescription/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2;—
2026-04-21US FDA — Medical DevicesDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;—
2026-04-21US FDA — Medical DevicesDescription/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-4556—
2026-04-10US FDA — Medical DevicesArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151—
2026-04-10US FDA — Medical DevicesArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I—
2026-04-10US FDA — Medical DevicesNextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-—
2026-04-10US FDA — Medical DevicesCannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152—
2024-04-29US FDA — Medical DevicesArrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS—
2024-04-29US FDA — Medical DevicesArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U—
2024-04-29US FDA — Medical DevicesArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U—

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