The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 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 993 (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.

3326–3350 of 3438

  • SevereFDA (Drugs)·D-280-2013·2013-05-01

    Axium Healthcare Recalls Comprehensive Injection #4 Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-290-2013·2013-05-01

    FDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-292-2013·2013-05-01

    HCG Lyophilized Powder Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.

    Product
    HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-271-2013·2013-05-01

    Methylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-291-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Acetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Acetonide Injectable due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-282-2013·2013-05-01

    Trimix Injectable Recalled by Axium Healthcare Pharmacy for Sterility Concerns

    Axium Healthcare Pharmacy is recalling Trimix injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-274-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-288-2013·2013-05-01

    Axium Healthcare Recalls DMSO Bladder Irrigation Solution Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.

    Product
    DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1062-2013·2013-04-17

    Synthes Flexible Grip Recalled for Cleaning Limitations

    Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.

    Product
    Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2013·2013-04-10

    LeMaitre Stent Guide Recalled Due to Compromised Sterility

    LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.

    Product
    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2013·2013-04-10

    LeMaitre Vascular Recalls Glow 'N Tell Tape Due to Sterility Compromise

    LeMaitre Vascular is recalling Glow 'N Tell 20 cm Tape because manufacturing defects compromised the sterility of the devices.

    Product
    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-206-2013·2013-03-27

    Hospira Recalls Metronidazole Injection Bags Due to Sterility Concerns

    Hospira Inc. is recalling 567,624 bags of Metronidazole Injection due to a potential leak that compromises sterility.

    Product
    METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2013·2013-03-27

    Molded Products Recalls Sterile Hemodialysis Line Sets Due to Leaks

    Molded Products Inc is recalling 1,200 sterile access and return line sets used in hemodialysis because they leak at the connection site.

    Product
    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0848-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0843-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 19 NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0844-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 56 NeuroPath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2013·2013-02-27

    Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 10 units distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0857-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 25 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 34 units distributed worldwide.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Sterility Concerns

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide