The Recall Desk

Hazard

Infection recalls

2,518 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,518
Critical
31
Severe
1,671
Most recent
2026-08-26

Of the 2,518 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,671 (66%) 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 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.

826–850 of 2518

  • HighFDA (Devices)·Z-2263-2018·2018-06-27

    TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2262-2018·2018-06-27

    TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.

    Product
    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2231-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2018·2018-06-27

    TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps

    TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2233-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential risk of infection.

    Product
    BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Packaging Defects

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 304 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 2,396 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2018·2018-06-20

    Angiodynamics Recalls CAN 5F Dual Xcela PICC Kits for Endotoxin Risk

    Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1978-2018·2018-06-06

    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) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Packaging Defect

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

    Product
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

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

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2018·2018-06-06

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc. is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2018·2018-06-06

    Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.

    Product
    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2018·2018-06-06

    Arrow PICC Sets Recalled Due to Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 PICC sets because unsealed packaging may have compromised product sterility.

    Product
    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-35552-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling specific lots of Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2018·2018-06-06

    Arrow International Recalls 9 Fr. Radiopaque Polyurethane Sheath Due to Packaging Defect

    Arrow International Inc is recalling 416,055 units of 9 Fr. Radiopaque Polyurethane Sheath/Dilator because unsealed packaging may compromise product sterility.

    Product
    9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.

    Product
    Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0729-2018·2018-05-16

    Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns

    Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0730-2018·2018-05-16

    Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns

    Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.

    Product
    Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
    Category
    Drug
    Distribution
    0 states