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.

1876–1900 of 3429

  • HighFDA (Devices)·Z-2791-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2790-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2788-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2783-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0999-2017·2017-08-02

    SCA Pharmaceuticals Recalls Morphine Sulfate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 220 bags of morphine sulfate in 0.9% sodium chloride because the product was made with recalled saline bags that may leak, compromising sterility.

    Product
    morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0994-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0995-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0989-2017·2017-07-26

    PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMedium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0985-2017·2017-07-26

    PharMedium Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    PharMedium Services is recalling specific lots of Succinylcholine Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0993-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0996-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure at the manufacturer that raises concerns about sterility.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Lan
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0986-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 S
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0990-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 1,528,000 units of 3ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.

    Product
    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2750-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.

    Product
    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2749-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 57,600 units of BD 3ml Syringes with PrecisionGlide Needles because some lots did not receive the required dose of irradiation to ensure sterility.

    Product
    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide