company
ARROW INTERNATIONAL, LLC
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, A…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MID…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PIC…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYS…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PI…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT:…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-2…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUME…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT:…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIM…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 2…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5…
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: ACCESS TRAY/ASK-04001-MC3
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PARACENTESIS KIT/ASK-00376-JHH
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
- fda_recall · device_recall2026-06-24ARROW INTERNATIONAL, LLC — Class I recall: Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 F…
- fda_recall · device_recall2026-05-20ARROW INTERNATIONAL, LLC — Class I recall: Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS…
- fda_recall · device_recall2026-05-20ARROW INTERNATIONAL, LLC — Class I recall: Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-…
- fda_recall · device_recall2026-05-20ARROW INTERNATIONAL, LLC — Class I recall: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-V…
- fda_recall · device_recall2026-05-20ARROW INTERNATIONAL, LLC — Class I recall: NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022203…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 F…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS C…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1…
- fda_recall · device_recall2026-04-29ARROW INTERNATIONAL, LLC — Class II recall: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1080…
Frequently asked questions
- How many FDA warning letters has ARROW INTERNATIONAL, LLC received?
- Argus HQ has not recorded an FDA warning letter for ARROW INTERNATIONAL, LLC in our current dataset.
- What FDA recalls has ARROW INTERNATIONAL, LLC issued?
- Argus HQ has recorded 47 FDA recalls tied to ARROW INTERNATIONAL, LLC.
- Is ARROW INTERNATIONAL, LLC FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 47 recalls, and 0 approval records for ARROW INTERNATIONAL, LLC. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.

