The Recall Desk

Manufacturer

ARROW INTERNATIONAL Inc.

478 recalls in our database name ARROW INTERNATIONAL Inc. as the manufacturing or recalling firm.

What the numbers show

Total
478
Critical
1
Severe
136
Most recent
2024-10-02

Of the 478 recalls from ARROW INTERNATIONAL Inc. we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 136 (28%) are Severe.

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.

126–150 of 478

  • SevereFDA (Devices)·Z-1180-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1174-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1179-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1209-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1176-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1182-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1217-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1202-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1207-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0844-2020·2020-01-29

    Arrow Arterial Catherization Kit Recalled for Incorrect MR Labeling

    Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.

    Product
    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial ci
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0715-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Leak

    Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak

    Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0192-2020·2019-10-30

    Arrow AGB+ Multi-Lumen CVC Kit Recalled for Incorrect Lidstock Labeling

    Arrow International Inc is recalling 745 units of the AGB+ Multi-Lumen CVC Kit because the lidstock label incorrectly lists the product code and catheter length.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2020·2019-10-16

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 3,143 Pediatric Two-Lumen Central Venous Catheterization Kits due to a labeling error on the lidstock.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2556-2019·2019-10-02

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Banner Card

    Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.

    Product
    Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2555-2019·2019-10-02

    Arrow International Recalls Central Venous Access Kits Due to Incorrect Banner Card

    Arrow International Inc is recalling 520 units of ARROW+gard Blue PSI Kit Cath-Gard central venous access devices because they may contain the incorrect banner card.

    Product
    8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2019·2019-06-26

    Arrow JACC Central Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 191 units of JACC central catheters because the expiration date printed on the product is incorrect.

    Product
    Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
    Category
    Medical Device
    Distribution
    Distributed nationwide