The Recall Desk

Hazard

Performance Standard recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2012-11-14

Of the 2 performance standard 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 performance standard 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.

1–2 of 2

  • ModerateFDA (Devices)·Z-0260-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding beam quality.

    Product
    R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0261-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.

    Product
    R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide