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.

726–750 of 3429

  • HighFDA (Devices)·Z-1852-2022·2022-10-05

    YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall

    Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.

    Product
    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1779-2022·2022-10-05

    SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles

    SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.

    Product
    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1835-2022·2022-10-05

    Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach

    Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.

    Product
    Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2022·2022-09-28

    BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates

    CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.

    Product
    BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1760-2022·2022-09-28

    BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling

    CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk infection.

    Product
    BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1756-2022·2022-09-28

    BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels

    BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.

    Product
    BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1759-2022·2022-09-28

    BD MaxGuard Extension Set Recalled for Incorrect Expiration Year

    CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1753-2022·2022-09-28

    BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date

    BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.

    Product
    BD MaxGuard Extension Set, REF: ME1069
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1754-2022·2022-09-28

    BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year

    BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.

    Product
    BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1766-2022·2022-09-28

    HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment

    Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2022·2022-09-28

    BD MaxGuard Extension Set labeled with incorrect expiration year 2027

    46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.

    Product
    BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1755-2022·2022-09-28

    BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates

    CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.

    Product
    BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1758-2022·2022-09-28

    BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk

    CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Drugs)·D-1528-2022·2022-09-21

    TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.

    Product
    TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1524-2022·2022-09-21

    Injectable Steroid Product Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.

    Product
    TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1527-2022·2022-09-21

    TRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance

    Carolina Infusion is recalling TRI-MIX 30/1/20 Injectable vials due to lack of assurance of sterility. The recall affects multiple lots distributed nationwide.

    Product
    TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2022·2022-09-21

    Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise

    Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2022·2022-09-21

    Roadrunner PC Wire Guide Recalled for Sterility Testing Failure

    Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2022·2022-09-21

    Vascular Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2022·2022-09-21

    Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise

    Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2022·2022-09-21

    Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall

    Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2022·2022-09-21

    Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1519-2022·2022-09-21

    Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns

    Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.

    Product
    Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1531-2022·2022-09-21

    Injectable drug recalled due to lack of sterility assurance

    Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.

    Product
    TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1534-2022·2022-09-21

    FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure

    Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.

    Product
    QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
    Category
    Drug
    Distribution
    Distributed nationwide