The Recall Desk

Hazard

Fungal Contamination recalls

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

What the numbers show

Total
67
Critical
11
Severe
22
Most recent
2026-09-23

Of the 67 fungal contamination recalls we have scored against our rubric, 11 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (33%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all fungal contamination 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.

1–25 of 67

  • CriticalFDA (Devices)·Z-3125-2026·2026-09-23

    Medline Convenience Kits Recalled for Fungal Contamination Risk

    Medline Industries is recalling specific lots of Convenience Kits due to potential fungal contamination that could lead to serious adverse health consequences.

    Product
    Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3122-2026·2026-09-23

    Medline Convenience Kits Recalled for Potential Fungal Contamination

    Medline is recalling 489 convenience kits nationwide because they may contain sterile applicators contaminated with Aspergillus penicillioides, which can cause serious infection.

    Product
    Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3127-2026·2026-09-23

    Medline Recalls Blood and Urine Collection Kits Due to Fungal Contamination

    Medline is recalling 47,848 blood and urine collection kits nationwide because they may contain Aspergillus penicillioides, a fungus that can cause serious infection.

    Product
    Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3126-2026·2026-09-23

    Medline Convenience Kits Recalled for Potential Fungal Contamination

    Medline Industries is recalling 1,100 convenience kits nationwide due to potential Aspergillus penicillioides contamination in sterile applicators.

    Product
    Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3121-2026·2026-09-23

    Medline Anesthesia Kits Recalled for Fungal Contamination Risk

    Medline is recalling specific lots of Anesthesia L&D A-Line Sets due to potential Aspergillus penicillioides contamination in sterile applicators.

    Product
    Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3123-2026·2026-09-23

    Medline Convenience Kits Recalled for Fungal Contamination Risk

    Medline Industries is recalling 447 convenience kits nationwide due to potential fungal contamination that could cause serious health consequences.

    Product
    Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3124-2026·2026-09-23

    Medline Convenience Kits Recalled for Fungal Contamination Risk

    Medline is recalling 10,407 convenience kits containing sterile applicators that may be contaminated with Aspergillus penicillioides, posing a risk of serious infection.

    Product
    Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0624-2026·2026-07-01

    ChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0625-2026·2026-07-01

    ChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns

    CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2026·2026-01-21

    Cell wash solution recalled over fungal contamination of an affected lot

    Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.

    Product
    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2025·2025-07-09

    Zicam Nasal AllClear swabs recalled over fungal contamination of swabs

    Zicam Nasal AllClear swabs are being recalled because of fungal contamination of the nasal swabs. All lots are affected, covering 13,632 cartons.

    Product
    ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0506-2025·2025-07-09

    Orajel Baby teething swabs recalled over fungal contamination of swabs

    Orajel Baby Cooling Swabs for Teething are being recalled because of fungal contamination of the infant oral swabs. All lots are affected, covering 695,880 cartons.

    Product
    Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2025·2025-07-09

    Zicam cold remedy nasal swabs recalled over fungal contamination

    Zicam Cold Remedy Medicated Nasal Swabs are being recalled because of fungal contamination of the swabs. All lots are affected, covering 3,374,918 cartons.

    Product
    ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2024·2024-04-17

    KWIK-STIK Quality Control Kit Recalled for Fungal Contamination

    Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.

    Product
    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0043-2022·2021-11-03

    Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-1786-2021·2021-06-16

    Medical Convenience Kits Recalled Due to Mold Contamination Risk

    Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.

    Product
    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1785-2021·2021-06-16

    Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination

    Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.

    Product
    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2021·2021-05-26

    Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination

    Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1624-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth

    Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0268-2021·2021-03-03

    FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk

    CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    1 state