The Recall Desk

FDA (Devices) recall action 98793

ARROW INTERNATIONAL, LLC recalled 35 products on 2026-06-24

The FDA (Devices) publishes a recall like this one as 35 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 35 pages.

Products
35
Announced
2026-06-24
Critical
0
Units
6,637,323

Why these products were recalled

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 35

  • SevereFDA (Devices)··2026-06-24

    Arrow drainage and thoracentesis kits contain recalled supplier drugs

    Arrow drainage and thoracentesis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 444,943 units are affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow access trays and PSI kits contain recalled supplier drugs

    Arrow access trays and PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 426,041 units are affected.

    Product
    Description/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 (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow paracentesis kit JHH contains drugs from a recalled supplier

    The Arrow paracentesis kit, REF ASK-00376-JHH, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 180 units affected.

    Product
    Description/REF: PARACENTESIS KIT/ASK-00376-JHH
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow peritoneal lavage catheter kits contain recalled supplier drugs

    The Arrow peritoneal lavage catheter kit, 8 Fr, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 7,560 units affected.

    Product
    Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow access trays and StimuCath kits contain recalled supplier drugs

    Arrow access trays and StimuCath safety kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 205,685 units affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow single lumen CVC kits contain drugs from recalled supplier

    Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 35,540 units are affected.

    Product
    Description/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-04711
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow paracentesis kits contain drugs from a recalled supplier

    Arrow paracentesis kits, REF AK-00376 and ASK-00376-VCU, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 50,724 units affected.

    Product
    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow PICC and delta kits contain recalled supplier drugs

    Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 3,481 units affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow PI CVC kits contain drugs from a recalled supplier

    Arrow PI CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.

    Product
    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+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow hemodialysis catheter kits contain drugs from a recalled supplier

    Arrow two-lumen hemodialysis kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,425 units affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow hemodialysis and AHDC kits contain recalled supplier drugs

    Arrow hemodialysis and AHDC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 62,719 units affected.

    Product
    Description/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: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow peripherally inserted JACC kits contain recalled supplier drugs

    Arrow PI JACC and AGBA PI JACC catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,516 units affected.

    Product
    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+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA P
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow PI midline 5 Fr kits contain recalled supplier drugs

    The Arrow PI Midline two-lumen 5 Fr x 20 cm kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 90 units affected.

    Product
    Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow midline catheter kits contain drugs from a recalled supplier

    Arrow midline catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 177,014 units are affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow antimicrobial PSI kits contain drugs from a recalled supplier

    Arrow PSI and PSI/CVC kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 348,684 units are affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow biopsy system comprehensive kits contain recalled supplier drugs

    Arrow Biopsy System Comprehensive Kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 14,840 units affected.

    Product
    Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow central venous catheter kits contain drugs from a recalled supplier

    Arrow central venous catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 308,263 units affected.

    Product
    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-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULT
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow PSI catheter kits contain drugs from a recalled supplier

    A further group of Arrow PSI kits is being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 72,354 units are affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow radial artery and arterial line kits contain recalled drugs

    Arrow radial artery catheter and arterial line kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 785,999 units affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow arterial line and vessel catheter kits contain recalled drugs

    Arrow arterial line, radial artery and vessel catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall.

    Product
    Description/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 TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow spinal anesthesia kits contain drugs from a recalled supplier

    Arrow spinal anesthesia kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 79,614 units are affected.

    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
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow AHDC catheter kits contain drugs from a recalled supplier

    Arrow AHDC three-lumen catheter kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 4,270 units affected.

    Product
    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-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow pacing and PSI kits contain drugs from a recalled supplier

    Arrow Pacing/PSI kits, 5 Fr two-lumen, are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 95 units affected.

    Product
    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow 12 Fr hemodialysis kit contains drugs from a recalled supplier

    The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.

    Product
    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2026-06-24

    Arrow PICC stylet and VPS access kits contain recalled drugs

    Arrow AGBA PICC G4 Stylet kits and VPS access kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 11,358 units affected.

    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
    Distribution
    52 states