The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all infection risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1751–1775 of 3429

  • HighFDA (Devices)·Z-1962-2018·2018-06-06

    Arrow International Recalls SnapLock Catheter/Syringe Adapters Due to Packaging Defect

    Arrow International is recalling SnapLock Catheter/Syringe Adapters because unsealed packaging may compromise sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2018·2018-06-06

    Arrow International Recalls PICC Catheter Trimmers Due to Packaging Defects

    Arrow International is recalling 416,055 PICC Catheter Trimmers because unsealed packaging may compromise product sterility. The recall covers units distributed in the US and 34 other countries.

    Product
    PICC Catheter Trimmer ; Product Code:PC-00001-T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2018·2018-06-06

    Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes

    Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes because unsealed packaging may compromise product sterility.

    Product
    10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 two-lumen central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2018·2018-06-06

    Arrow International Recalls Sheath Adapters Due to Compromised Sterility

    Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.

    Product
    Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2018·2018-06-06

    Arrow PICC Set Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.

    Product
    ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2018·2018-06-06

    Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect

    Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    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. Catheters ; Product Codes: ASK-09903-UM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1976-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Issues

    Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled

    COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.

    Product
    BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0728-2018·2018-05-16

    Vitalab Methylcobalamin Injection Recalled Due to Sterility Concerns

    Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1640-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2018·2018-05-16

    Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.

    Product
    Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2018·2018-05-16

    Microline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns

    Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.

    Product
    ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1633-2018·2018-05-16

    Vygon Recalls PICC Insertion Kits Due to Sterility Risk

    Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.

    Product
    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1637-2018·2018-05-16

    Vygon Recalls PICC Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2018·2018-05-16

    Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips

    Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.

    Product
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endo
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1590-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns

    Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
    Category
    Medical Device
    Distribution
    Distributed nationwide