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

26–35 of 35

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…
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…
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 access trays contain drugs from a recalled supplier
The Arrow PICC Access Tray, REF ASK-04001-CG1, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 360 units affected.
Product
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Category
Distribution
52 states
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…
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 pacing PSI kits contain drugs from a recalled supplier
Arrow Pacing PSI kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 15,915 units are affected.
Product
Description/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-07155-UPM
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…
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…
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…
Category
Distribution
52 states