The Recall Desk

Hazard

Non Sterile Component recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2025-07-30

Of the 6 non sterile component recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 component 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.

1–6 of 6

  • HighFDA (Devices)·Z-2135-2025·2025-07-30

    HSG procedure trays label non-sterile iodine pouches as sterile

    HSG Procedure Trays are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 171 units are affected.

    Product
    HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2025·2025-07-30

    Endosee convenience kits label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.

    Product
    Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2025·2025-07-30

    Endosee system convenience trays label non-sterile iodine pouches as sterile

    Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.

    Product
    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2023·2023-08-09

    Medline surgical procedure kits recalled for potential sterility defect

    Medline Industries is recalling 43,149 custom sterile and non-sterile procedural kits because the included Turkuaz ultrasound gel may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2023·2023-08-09

    Medical procedural kits recalled due to sterility concerns with ultrasound gel

    Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2269-2014·2014-08-27

    Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales

    Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.

    Product
    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists
    Category
    Medical Device
    Distribution
    Distributed nationwide