PlainRecalls

Arrow International Inc

Compiled from official public sources by the editorial team.

478 recalls on record · Latest: Oct 2, 2024

Arrow International Inc Recall Insight

Arrow International Inc appears on 478 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.470% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 2, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 11 critical, 39 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 47 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 19, 2020 to Nov 24, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Nov 24, 2021

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolyti…

FDA Devices Moderate Jul 21, 2021

Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysi…

FDA Devices Moderate Jul 21, 2021

Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporar…

FDA Devices Moderate Jul 21, 2021

Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studi…

FDA Devices Moderate Jul 21, 2021

Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for tempor…

FDA Devices Moderate Apr 14, 2021

Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold…

FDA Devices Moderate Feb 17, 2021

Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian …

FDA Devices Moderate Aug 19, 2020

Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been…

FDA Devices Moderate Aug 19, 2020

NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly tha…

FDA Devices Moderate Aug 19, 2020

Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.

FDA Devices Moderate Aug 19, 2020

Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500

FDA Devices Critical Jul 8, 2020

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

FDA Devices Critical Jul 8, 2020

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

FDA Devices Critical Jul 8, 2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E

FDA Devices Moderate Jun 17, 2020

Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Cod…

FDA Devices Moderate Feb 26, 2020

Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1

FDA Devices Moderate Feb 26, 2020

Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH

FDA Devices Moderate Feb 26, 2020

PICC Set- PR-35052-HPHNM

FDA Devices Moderate Feb 26, 2020

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

FDA Devices Moderate Feb 26, 2020

Arrow Central Venous Catheterization Kit ASK-04200-UPM

FDA Devices Moderate Feb 26, 2020

Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

FDA Devices Moderate Feb 26, 2020

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL CATHETERIZATION KIT YC-02220

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000

FDA Devices Moderate Feb 26, 2020

Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL CATHETERIZATION KIT CK-02220

FDA Devices Moderate Feb 26, 2020

(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPN…

FDA Devices Moderate Feb 26, 2020

Arrow Maximal Barrier Drape ASK-00002-1A

FDA Devices Moderate Feb 26, 2020

Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL CATHETERIZATION KIT AM-05500

FDA Devices Moderate Feb 26, 2020

Arrow SPINAL ANESTHESIA SET ASA-25090-S

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL NEEDLE KIT SL-05500

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL CATHETERIZATION KIT JH-05500

FDA Devices Moderate Feb 26, 2020

Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000

FDA Devices Moderate Feb 26, 2020

Arrow EPIDURAL NEEDLE COMPONENT AN-05505

FDA Devices Moderate Feb 19, 2020

Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY

FDA Devices Moderate Feb 19, 2020

FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1

FDA Devices Moderate Feb 19, 2020

EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC

FDA Devices Moderate Feb 19, 2020

EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB

FDA Devices Moderate Feb 19, 2020

FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS

FDA Devices Moderate Feb 19, 2020

FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P

FDA Devices Moderate Feb 19, 2020

FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E

FDA Devices Moderate Feb 19, 2020

TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.