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.

1101–1125 of 3429

  • HighFDA (Devices)·Z-1760-2021·2021-06-09

    ZVplasty System spinal implant recalled due to inadequate sterilization

    Zavation is recalling ZVplasty System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.

    Product
    ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2021·2021-06-09

    Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

    Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site infection.

    Product
    10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2021·2021-06-09

    Zavation Direct Working Cannula Recalled for Sterilization Defect

    Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2021·2021-06-09

    Zavation 10 Gauge Direct Access Diamond Tip Devices Recalled for Sterilization

    Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip devices (Lot 11285ZV, 2001200) distributed nationwide for orthopedic spinal procedures because they may not have been adequately sterilized.

    Product
    10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2021·2021-06-09

    Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization

    Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.

    Product
    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2021·2021-06-09

    Zavation Vertebrex Spinal Balloon Kit May Not Be Properly Sterilized

    Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet sterility standards.

    Product
    VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2021·2021-06-09

    Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized

    Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.

    Product
    10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2021·2021-06-09

    Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization

    Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.

    Product
    InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2021·2021-06-09

    Oral Surgery Devices Recalled for Potential Sterility Failures

    Meta C.G.M. Spa is recalling MICROSS oral surgery devices due to sterility concerns. Units labeled as sterile may not have been adequately sterilized.

    Product
    REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1747-2021·2021-06-09

    Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization

    Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.

    Product
    10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2021·2021-06-09

    Tranberg MR Stylet Recalled Due to Inadequate Sterilization

    CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.

    Product
    Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2021·2021-06-09

    Spinal Surgery Cement Delivery Cannula Kits Recalled for Potential Sterilization Failure

    Zavation is recalling ZVplasty Unipedicular Cement Delivery Cannula Kits distributed nationwide due to potential inadequate sterilization of sterile surgical devices.

    Product
    ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2021·2021-05-19

    Fresenius AquaBplus Water Purification System Recalled for Installation Error

    Fresenius Medical Care is recalling 27 AquaBplus water purification systems because an installation guideline error may reduce the effectiveness of heat disinfection.

    Product
    AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 uni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2021·2021-05-05

    Omnia Soft Tissue Punch Recalled Due to Inadequate Sterilization

    Omnia SRL is recalling dental soft tissue punches because the contract manufacturer reported inadequate sterilization processes at their facility since 2016.

    Product
    Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1467-2021·2021-04-28

    AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

    AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

    Product
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2021·2021-04-14

    ROi CPS Recalls Regard Custom Cardiovascular Procedure Kits

    ROi CPS LLC is recalling 16 Regard custom cardiovascular procedure kits because drape slits may breach the sterile barrier.

    Product
    Regard, Item Number 830067009, custom cardiovascular procedure kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2021·2021-04-14

    Sharp Medical Reactor and Sleeve Recalled for Sterile Barrier Defects

    Sharp Medical Products is recalling 129 units of Reactor and Sleeve REF 100-36-01 due to holes, punctures, or deep creases in the sterile barrier.

    Product
    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1248-2021·2021-03-17

    Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise

    Medtronic Vascular is recalling 137 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.

    Product
    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0281-2021·2021-03-03

    Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2021·2021-03-03

    Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2021·2021-03-03

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.

    Product
    Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2021·2021-03-03

    Teva Recalls Vecuronium Bromide Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Vecuronium Bromide for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2021·2021-03-03

    Teva Recalls Epoprostenol Sodium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2021·2021-03-03

    Teva Recalls Dacarbazine Injection Due to Sterility Assurance Concerns

    Teva Pharmaceuticals is recalling Dacarbazine for Injection USP because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.

    Product
    Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide