The Recall Desk

Hazard

Uncleared Use recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2013-11-06

Of the 5 uncleared use 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 uncleared use 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.

1–5 of 5

  • HighFDA (Devices)·Z-0095-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0096-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 100 units of Pipeline LS Dilators because they were used for neuromonitoring, a function for which the device is not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0097-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Holding Clips for Uncleared Use

    DePuy Spine is recalling 198 Pipeline LS Holding Clips because they were used for neuromonitoring, a function for which the device is not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0094-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2014·2013-11-06

    DePuy Spine Pipeline LS Dilator Recall for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 118 Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide