The Recall Desk

Hazard

Performance Shortfall recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-06-17

Of the 3 performance shortfall 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 shortfall 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-2403-2026·2026-06-17

    Boston Scientific reusable TCN nitinol electrodes may underperform expected levels

    Boston Scientific TCN nitinol electrodes across four lengths are being recalled because the reusable electrodes may not meet expected performance levels. 49,251 units affected.

    Product
    Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2026·2026-06-17

    Boston Scientific reusable CSK stainless steel electrodes may underperform expected levels

    Boston Scientific CSK stainless steel electrodes across several lengths are being recalled because the reusable electrodes may not meet expected performance levels. 31,923 units affected.

    Product
    Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2026·2025-11-19

    Oxygenators recalled after a unit failed carbon dioxide transfer requirements

    Medtronic Perfusion Systems is recalling 26 Affinity NT Oxygenators after identifying a unit with decreased CO2 gas transfer rates that did not meet performance requirements.

    Product
    Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
    Category
    Medical Device
    Distribution
    3 states