The Recall Desk

Hazard

Infection Risk recalls

1,010 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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.

101–125 of 1010

  • HighFDA (Drugs)·D-0049-2026·2025-10-15

    Calcium Chloride for Injection Recalled Due to Sterility Concerns

    GenoGenix LLC is recalling all lots of Calcium Chloride for Injection nationwide due to lack of sterility assurance. Patients should discontinue use and contact their healthcare provider.

    Product
    Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2026·2025-10-15

    Tesamorelin Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling Tesamorelin for Injection nationwide due to lack of assurance that sterile manufacturing standards are met. Patients should contact their healthcare provider.

    Product
    Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0046-2026·2025-10-15

    Bacteriostatic Water for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling all lots of Bacteriostatic Water for Injection nationwide due to lack of assurance of sterility, a serious concern for any injectable product.

    Product
    Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2026·2025-10-15

    Proline for Injection recalled for lack of sterility assurance

    GenoGenix LLC is recalling all lots of Proline for Injection due to lack of assurance of sterility. Patients should contact their healthcare provider to discuss treatment options.

    Product
    Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0085-2026·2025-10-15

    BPC-157 Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling BPC-157 for Injection nationwide due to lack of assurance of sterility in the manufacturing process. The product may contain microbial contamination, posing a risk to patients receiving injections.

    Product
    BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2026·2025-10-15

    Zinc Chloride for Injection Recalled Nationwide Due to Sterility Concerns

    GenoGenix LLC is recalling all lots of Zinc Chloride for Injection nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.

    Product
    Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0062-2026·2025-10-15

    Magnesium Chloride for Injection Recalled for Sterility Assurance Issues

    GenoGenix is recalling Magnesium Chloride for Injection (all strengths and presentations) due to lack of sterility assurance. Approximately 430 units were distributed nationwide.

    Product
    Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0003-2026·2025-10-15

    Bevacizumab Intravitreal Injections Recalled for Lack of Sterility Assurance

    RC Outsourcing is recalling Bevacizumab intravitreal injections due to lack of assurance of sterility. The recall affects 2,669 syringes distributed nationwide.

    Product
    Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0083-2026·2025-10-15

    Semaglutide with B12 Injectable Recalled for Sterility Assurance Issues

    GenoGenix LLC is recalling Semaglutide with B12 for Injection nationwide due to lack of assurance of sterility. Consumers should stop using this product and consult their healthcare provider.

    Product
    Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2026·2025-10-15

    Biotin for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling Biotin for Injection nationwide due to lack of assurance of sterility. The injectable product does not meet required sterility standards.

    Product
    Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0067-2026·2025-10-15

    Injectable drug Tri-Immune recalled over sterility assurance issues

    GenoGenix LLC is recalling all lots of Tri-Immune for Injection due to lack of assurance of sterility. The injectable medication is being recalled nationwide.

    Product
    Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2592-2025·2025-10-08

    Medline Sterile Medical Device Convenience Kits Recalled for Missing Sterilization

    Medline Industries is recalling two sterile convenience kit models because the products were not sterilized despite being labeled as sterile. The kits were distributed to Florida, Maryland, New Jersey, and Tennessee.

    Product
    Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2593-2025·2025-10-08

    Medline sterile convenience kits recalled for lacking sterilization

    Medline Industries recalls 88 Extremity Pack convenience kits that were labeled as sterile but did not undergo sterilization. The affected units were distributed to healthcare facilities in Florida, Maryland, New Jersey, and Tennessee.

    Product
    Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0021-2026·2025-10-08

    FDA Recalls Laser Atherectomy Catheter Due to Sterile Barrier Breach Risk

    Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in the sterile barrier packaging. The compromised sterility could increase infection risk during vascular procedures.

    Product
    NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    NES Reprocessed Laser Atherectomy Catheter Recalled for Sterile Packaging Breach

    Northeast Scientific Inc. is recalling 1,019 units of its NES Reprocessed 1.4mm Turbo Elite Laser Atherectomy Catheter (Model R-414-159) due to potential sterile barrier breaches that could compromise device sterility.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0033-2026·2025-10-08

    Medtronic Simplera Sensor cap may not adhere properly to sensor

    Medtronic is recalling the Simplera Sensor because the device cap label may not adhere properly to the sensor, potentially compromising its sterility. This increases the risk of infection.

    Product
    Medtronic, Simplera Sensor, REF: MMT-5100JD1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0022-2026·2025-10-08

    Medical Catheter Recalled for Potential Sterile Barrier Packaging Breaches

    Northeast Scientific is recalling 795 units of the NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise device sterility.

    Product
    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2025·2025-10-01

    Sofmed Breathables contact lens recall due to invalid sterilization cycle

    CooperVision is recalling one lot of Sofmed Breathables contact lenses due to manufacturing with an invalid sterilization cycle. The affected lenses may not be properly sterilized and could pose a risk to eye health.

    Product
    Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2025·2025-10-01

    CooperVision MyDay Toric contact lenses recalled for invalid sterilization

    CooperVision is recalling one lot of MyDay Toric contact lenses distributed in four U.S. states. One manufacturing lot was processed with an invalid sterilization cycle, which could affect product sterility.

    Product
    MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2025·2025-09-24

    Foley Catheter Tray System Recalled Due to Incorrect Component Materials

    C.R. Bard is recalling 4,300 SureStep Foley Tray System units with incorrect catheter inserts that may mislead users about material type and antimicrobial coating, risking allergic reactions and infections.

    Product
    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2025·2025-09-24

    Foley Catheter Trays With Incorrect Material Identification Labels

    SureStep Foley catheter trays are being recalled because their inserts have incorrect material labels. Users may confuse latex with silicone or vice versa, which could cause allergic reactions or infections.

    Product
    SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2025·2025-09-24

    Foley Catheter Tray System Recalls Due to Incorrect Material Inserts

    SureStep Foley Tray System units contain incorrect inserts labeled incorrectly, risking patient allergic reactions and infections if the wrong material type is used.

    Product
    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2025·2025-09-03

    Obstetric procedure kits recalled due to unconfirmed sterilization assurance

    American Contract Systems is recalling 781 medical procedure kits because the manufacturer cannot confirm sterilization was properly completed. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Surgical procedure kits recalled due to sterilization assurance concerns

    American Contract Systems Inc is recalling hysterectomy procedure kits from IL and LA due to inability to confirm sterilization assurance requirements were met.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2470-2025·2025-09-03

    Medical Surgery Kits Recalled for Sterilization Assurance Failure

    American Contract Systems is recalling 1,094 laparoscopy and pelviscopy procedure kits distributed to Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
    Category
    Medical Device
    Distribution
    2 states