The Recall Desk

Hazard

Inadequate Sterilization recalls

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

What the numbers show

Total
92
Critical
0
Severe
2
Most recent
2026-08-19

Of the 92 inadequate sterilization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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 inadequate sterilization 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.

26–50 of 92

  • 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-1755-2021·2021-06-09

    InterV 11G Kyphoplasty Kit Recall: Sterilization Defect May Increase Infection Risk

    Zavation is recalling 119 InterV 11G Kyphoplasty Kits distributed nationwide because they may not have been adequately sterilized, which could increase the risk of infection during spinal surgery.

    Product
    InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2021·2021-06-09

    Zavation ZVplasty Orthopedic System Recalled for Inadequate Sterilization

    Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.

    Product
    ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2021·2021-06-09

    InterV Kyphoplasty Spinal Devices Recalled for Inadequate Sterilization

    Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 units distributed nationwide.

    Product
    InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-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-1758-2021·2021-06-09

    Zavation ZVplasty Double Balloon Kit Recalled Due to Inadequate Sterilization

    Zavation recalls ZVplasty 10G, 10mm Double Balloon Kits used in spinal surgery due to potential inadequate sterilization. Seven units distributed nationwide may not have met sterility standards.

    Product
    ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. 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-1736-2021·2021-06-09

    11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization

    Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.

    Product
    11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2021·2021-06-09

    ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.

    Product
    ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
    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-1744-2021·2021-06-09

    Zavation Orthopedic Cement Delivery System Recalled for Sterilization Failure

    Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2021·2021-06-09

    Orthopedic spinal surgical device recalled for inadequate sterilization

    Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.

    Product
    10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2021·2021-06-09

    ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.

    Product
    ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2021·2021-06-09

    ZVplasty Directional Cement Cannula recalled for inadequate sterilization

    Zavation is recalling 11 units of ZVplasty Directional Cement Cannula from lot 20061366 because products distributed as sterile may not have been adequately sterilized. The affected devices were distributed nationwide.

    Product
    ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2021·2021-06-09

    ZVplasty Orthopedic Spinal System Units Recalled Due to Inadequate Sterilization

    Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.

    Product
    ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2021·2021-06-09

    Orthopedic spinal implants recalled due to inadequate sterilization

    Zavation is recalling 7 units of 11G DIRECT SINGLE spinal implants (lots 2001185 and 2001243) because products distributed as sterile may not have been adequately sterilized. The devices were distributed nationwide.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1720-2021·2021-06-09

    Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization

    Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2021·2021-06-09

    ZVplasty Spinal Bone Access Kit Recall Due to Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits due to inadequate sterilization. Products distributed as sterile nationwide may pose infection risk if used in spinal procedures.

    Product
    ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
    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-1740-2021·2021-06-09

    Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

    Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.

    Product
    10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2021·2021-06-09

    ZVplasty System spinal implant devices recalled for inadequate sterilization

    Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.

    Product
    ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2021·2021-06-09

    Oral surgery scrapers recalled due to possible inadequate sterilization

    Meta C.G.M. Spa recalls 27 units of REF 4890 SMARTSCRAPER oral surgery instruments distributed in Texas and Florida. The sterile-labeled devices may not have been adequately sterilized.

    Product
    REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1718-2021·2021-06-09

    Spinal surgical cement delivery cannulas recalled for inadequate sterilization

    Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2021·2021-06-09

    Zavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization

    Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were distributed nationwide.

    Product
    10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2021·2021-06-09

    Zavation 10G Beveled Trocar/Cannula recalled for inadequate sterilization

    Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.

    Product
    10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide