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.

826–850 of 3429

  • SevereFDA (Drugs)·D-0667-2022·2022-03-23

    Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.

    Product
    Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0656-2022·2022-03-23

    Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.

    Product
    Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0658-2022·2022-03-23

    Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance

    Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0665-2022·2022-03-23

    Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.

    Product
    Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0662-2022·2022-03-23

    Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns

    Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.

    Product
    Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0772-2022·2022-03-23

    Medical device sterile barrier breach compromises sterility in JAGTOME RX

    Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.

    Product
    JAGTOME RX 39-30-450-025 Material Number: M00573110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2022·2022-03-23

    Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.

    Product
    DREAMTOME 44-30MM/450CM Material Number: M00584070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2022·2022-03-23

    Boston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.

    Product
    HYDRATOME RX 44-20MM/260CM Material Number: M00583040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2022·2022-03-23

    JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.

    Product
    JAGTOME RX 39-20-450-025 Material Number: M00573090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2022·2022-03-23

    Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach

    Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.

    Product
    RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2022·2022-03-23

    Sterile Barrier Breach in JAGTOME RX Medical Devices Worldwide

    Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.

    Product
    JAGTOME RX 39-20-260-025 Material Number: M00573080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2022·2022-03-23

    Sterile barrier breach recalled in Boston Scientific HYDRATOME RX catheters

    Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.

    Product
    HYDRATOME RX 49-20MM/260CM Material Number: M00583000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2022·2022-03-23

    Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier

    Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-450-035 Material Number: M00573050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2022·2022-03-23

    Medical Device Sterile Barrier Breach: JAGTOME RX Recall

    Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.

    Product
    JAGTOME RX 44-30-450-035 Material Number: M00573070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2022·2022-03-23

    Medical Device Recall: Boston Scientific JAGTOME RX Sterile Barrier Breach

    Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.

    Product
    JAGTOME RX 39-30-260-025 Material Number: M00573100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2022·2022-03-23

    Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise

    Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.

    Product
    DREAMTOME 49-30MM/260CM Material Number: M00584010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2022·2022-03-23

    Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach

    Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.

    Product
    Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2022·2022-03-23

    RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach

    Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.

    Product
    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2022·2022-03-23

    Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.

    Product
    JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2022·2022-03-23

    Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.

    Product
    JAGTOME RX 49-20-260-035 Material Number: M00573000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2022·2022-03-23

    DREAMTOME Medical Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.

    Product
    DREAMTOME 49-30MM/450CM Material Number: M00584030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2022·2022-03-23

    Boston Scientific DREAMTOME device recalled due to sterile barrier breach

    Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.

    Product
    DREAMTOME 44-30MM/260CM Material Number: M00584050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0761-2022·2022-03-23

    Boston Scientific Hydratome RX Devices Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.

    Product
    HYDRATOME RX 44-30MM/260CM Material Number: M00583050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2022·2022-03-16

    B. Braun dispensing pins recalled for air filter leakage risk

    B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.

    Product
    Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
    Category
    Medical Device
    Distribution
    Distributed nationwide