The Recall Desk

Manufacturer

ARROW INTERNATIONAL, LLC

47 recalls in our database name ARROW INTERNATIONAL, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 47

  • Severity pendingFDA (Devices)·Z-2392-2026·2026-06-24

    Description/REF: ACCESS TRAY/ASK-04001-MC3

    Pending LLM rewrite. Source: FDA_DEVICE Z-2392-2026.

    Product
    Description/REF: ACCESS TRAY/ASK-04001-MC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2395-2026·2026-06-24

    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

    Pending LLM rewrite. Source: FDA_DEVICE Z-2395-2026.

    Product
    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2382-2026·2026-06-24

    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTE

    Pending LLM rewrite. Source: FDA_DEVICE Z-2382-2026.

    Product
    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2363-2026·2026-06-24

    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

    Pending LLM rewrite. Source: FDA_DEVICE Z-2363-2026.

    Product
    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2367-2026·2026-06-24

    Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR

    Pending LLM rewrite. Source: FDA_DEVICE Z-2367-2026.

    Product
    Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2386-2026·2026-06-24

    Description/REF: PARACENTESIS KIT/ASK-00376-JHH

    Pending LLM rewrite. Source: FDA_DEVICE Z-2386-2026.

    Product
    Description/REF: PARACENTESIS KIT/ASK-00376-JHH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2371-2026·2026-06-24

    Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT:

    Pending LLM rewrite. Source: FDA_DEVICE Z-2371-2026.

    Product
    Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2380-2026·2026-06-24

    Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

    Pending LLM rewrite. Source: FDA_DEVICE Z-2380-2026.

    Product
    Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2389-2026·2026-06-24

    Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANES

    Pending LLM rewrite. Source: FDA_DEVICE Z-2389-2026.

    Product
    Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2394-2026·2026-06-24

    Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15C

    Pending LLM rewrite. Source: FDA_DEVICE Z-2394-2026.

    Product
    Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2383-2026·2026-06-24

    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

    Pending LLM rewrite. Source: FDA_DEVICE Z-2383-2026.

    Product
    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2364-2026·2026-06-24

    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G

    Pending LLM rewrite. Source: FDA_DEVICE Z-2364-2026.

    Product
    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2368-2026·2026-06-24

    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

    Pending LLM rewrite. Source: FDA_DEVICE Z-2368-2026.

    Product
    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-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2369-2026·2026-06-24

    Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 C

    Pending LLM rewrite. Source: FDA_DEVICE Z-2369-2026.

    Product
    Description/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; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2393-2026·2026-06-24

    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

    Pending LLM rewrite. Source: FDA_DEVICE Z-2393-2026.

    Product
    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-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2378-2026·2026-06-24

    Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-4455

    Pending LLM rewrite. Source: FDA_DEVICE Z-2378-2026.

    Product
    Description/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/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2373-2026·2026-06-24

    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 F

    Pending LLM rewrite. Source: FDA_DEVICE Z-2373-2026.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2384-2026·2026-06-24

    Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X

    Pending LLM rewrite. Source: FDA_DEVICE Z-2384-2026.

    Product
    Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2370-2026·2026-06-24

    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

    Pending LLM rewrite. Source: FDA_DEVICE Z-2370-2026.

    Product
    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 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURV
    Category
    Medical Device
    Distribution
    Distributed nationwide