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.

501–525 of 3438

  • SevereFDA (Devices)·Z-0515-2024·2023-12-27

    Sterile Water Syringes recalled for lack of sterility assurance

    Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.

    Product
    Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2024·2023-12-27

    Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy

    Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.

    Product
    Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0573-2024·2023-12-27

    Injection Needles Recalled for Inadequate Manual Cleaning Process

    Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.

    Product
    Injection Needle, LUER-lock,0.8mm, REF: 26175PD
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0574-2024·2023-12-27

    Injection needles recalled due to cleaning efficacy concerns

    Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.

    Product
    Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0572-2024·2023-12-27

    Injection needles and cannulas recalled for cleaning process efficacy issues

    Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.

    Product
    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0571-2024·2023-12-27

    Injection Needle Recall Due to Cleaning Process Concerns

    Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.

    Product
    Injection Needle, REF: 25207
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0528-2024·2023-12-20

    Sterile PVP Medical Solution Recalled for Non-Sterile Contents

    Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.

    Product
    STERILE PVP, REF DYNDA1649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2024·2023-12-20

    Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling

    Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.

    Product
    STERILE STERILE PREP STICK, REF DYNDA1134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2024·2023-12-13

    Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process

    Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0497-2024·2023-12-13

    Integra Cranial Access Kit recalled over outer packaging defect

    Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2024·2023-12-06

    Improperly Repaired Gastrointestinal Videoscope May Expose Patients to Contamination

    Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.

    Product
    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0415-2024·2023-12-06

    Olympus colonoscope repair defect may impair imaging and suction function

    Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.

    Product
    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0417-2024·2023-12-06

    Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk

    Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.

    Product
    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0419-2024·2023-12-06

    Olympus EVIS EXERA III Colonoscope Recall for Connector Defect

    24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.

    Product
    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0418-2024·2023-12-06

    Colonoscope Repair Defect May Cause Device Malfunction and Contamination Risk

    Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.

    Product
    PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0339-2024·2023-11-29

    Tracheal Videoscope Recall Due to Unvalidated Drying Process

    Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.

    Product
    Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2024·2023-11-29

    Ureteralscopes recalled due to unvalidated drying process and contamination risk

    Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.

    Product
    Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2024·2023-11-29

    Gastrointestinal videoscopes recalled due to unvalidated channel drying process

    Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.

    Product
    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2024·2023-11-29

    Endoscopic surgical instruments recalled for unvalidated drying process

    Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.

    Product
    Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2024·2023-11-29

    Uretero-reno fiberscopes recalled due to inadequate channel drying

    Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.

    Product
    Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2024·2023-11-29

    Ultrasonic Gastrovideoscope Model TGF-UC180J Recalled for Inadequate Channel Drying

    Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.

    Product
    Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2024·2023-11-29

    Small intestinal videoscope recalled due to inadequate channel drying process

    Aizu Olympus is recalling small intestinal videoscopes (Model SIF-Q180) because the channel air drying process was not properly validated. Water remaining in the channels could cause contamination and infection risk.

    Product
    Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2024·2023-11-29

    Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk

    Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.

    Product
    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2024·2023-11-29

    Hysteroscope Model HYF-1T recalled due to moisture in device channels

    Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.

    Product
    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2024·2023-11-29

    Bronchoscopes Recalled Due to Inadequate Air Drying Process

    Aizu Olympus recalls bronchoscopes due to unvalidated air drying process. Some returned units after repair contain water in channels, creating infection risk.

    Product
    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160…
    Category
    Medical Device
    Distribution
    Distributed nationwide