The Recall Desk

Hazard

Non Sterile Device recalls

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

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2023-03-08

Of the 7 non sterile device recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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 non sterile device 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.

1–7 of 7

  • HighFDA (Devices)·Z-1188-2023·2023-03-08

    Maquet CARDIOHELP System extracorporeal support device components recalled for sterility

    Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2022·2022-10-05

    YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall

    Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.

    Product
    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1139-2021·2021-03-03

    DeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.

    Product
    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0062-2021·2020-10-14

    Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability

    Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.

    Product
    Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2019·2019-08-14

    Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes

    Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.

    Product
    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2018·2018-05-23

    Southmedic Recalls Sterile Scalpels Labeled as Non-Sterile

    Southmedic, Inc. is recalling 3,300 sterile disposable scalpels because the product contains non-sterile items labeled as sterile.

    Product
    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2590-2014·2014-09-10

    Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits

    Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.

    Product
    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide