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 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 49 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 Jun 6, 2018 to Mar 6, 2019.

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 Moderate Mar 6, 2019

0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Mar 6, 2019

AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Mar 6, 2019

AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Mar 6, 2019

AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Mar 6, 2019

AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Mar 6, 2019

AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA Devices Moderate Jan 23, 2019

Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arr…

FDA Devices Moderate Nov 21, 2018

Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: T…

FDA Devices Moderate Nov 7, 2018

Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous a…

FDA Devices Moderate Sep 26, 2018

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

FDA Devices Moderate Sep 26, 2018

ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are…

FDA Devices Moderate Sep 26, 2018

5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

FDA Devices Moderate Aug 29, 2018

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multip…

FDA Devices Moderate Aug 22, 2018

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-…

FDA Devices Moderate Aug 22, 2018

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-…

FDA Devices Moderate Aug 8, 2018

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. T…

FDA Devices Moderate Jul 18, 2018

Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a…

FDA Devices Moderate Jul 18, 2018

VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by u…

FDA Devices Moderate Jul 18, 2018

VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by util…

FDA Devices Moderate Jul 18, 2018

VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central ven…

FDA Devices Moderate Jul 11, 2018

Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the cen…

FDA Devices Moderate Jun 6, 2018

4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

FDA Devices Moderate Jun 6, 2018

8Fr. Catheter Clamp with Fastener; Product Code: CC-00008

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Code: ASK-04000-HMC

FDA Devices Moderate Jun 6, 2018

Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703…

FDA Devices Moderate Jun 6, 2018

Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Cath…

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Pr…

FDA Devices Moderate Jun 6, 2018

Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Codes: ASK-00001-1A

FDA Devices Moderate Jun 6, 2018

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features;…

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A

FDA Devices Moderate Jun 6, 2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-4…

FDA Devices Moderate Jun 6, 2018

Epidural Needle; Product Codes: AN-05501 and AN-05505

FDA Devices Moderate Jun 6, 2018

VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

FDA Devices Moderate Jun 6, 2018

Radial Arterial Access Kit; Product Code: ASK-04001-BID2

FDA Devices Moderate Jun 6, 2018

Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1

FDA Devices Moderate Jun 6, 2018

Arterial Catheterization Kit; Product Code:NA-04550-1A

FDA Devices Moderate Jun 6, 2018

Extension Line Slide Clamps; Product codes: SA-09847

FDA Devices Moderate Jun 6, 2018

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Preca…

FDA Devices Moderate Jun 6, 2018

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF

FDA Devices Moderate Jun 6, 2018

Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

FDA Devices Moderate Jun 6, 2018

ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC

FDA Devices Moderate Jun 6, 2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Pre…

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA

FDA Devices Moderate Jun 6, 2018

PICC Catheter Trimmer ; Product Code:PC-00001-T

FDA Devices Moderate Jun 6, 2018

ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-355…

FDA Devices Moderate Jun 6, 2018

VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO

FDA Devices Moderate Jun 6, 2018

TheraCath(R) Epidural Catheter; Product Code: EC-05000

FDA Devices Moderate Jun 6, 2018

7Fr. Catheter Clamp with Fastener; Product Code: CC-00007

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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.