ARROW INTERNATIONAL, LLC

Frequent Recalls

Recalls

Units Recalled

Injuries

Deaths

2026-04-29 to 2026-06-24

Date	Source	Product	Brand	Severity	Units
2026-06-24	FDA Device	FDA Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/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-OSU	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT:	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/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-S	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 C	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTE	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING P	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-4455	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 F	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: 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+	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT:	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PARACENTESIS KIT/ASK-00376-JHH	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-MC3	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW;	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-P	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANES	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PICC ACCESS TRAY/ASK-04001-CG1	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; S	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15C	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-1	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-06-24	FDA Device	FDA Recall: Description/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	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-05-20	FDA Device	FDA Recall: Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-05-20	FDA Device	FDA Recall: NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-05-20	FDA Device	FDA Recall: Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, C	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-05-20	FDA Device	FDA Recall: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, A	ARROW INTERNATIONAL, LLC	Class I	N/A
2026-04-29	FDA Device	FDA Recall: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)108019021	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)1080	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-0	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI c	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)2512	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK	ARROW INTERNATIONAL, LLC	Class II	N/A
2026-04-29	FDA Device	FDA Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-	ARROW INTERNATIONAL, LLC	Class II	N/A