The Recall Desk

Hazard

Reduced Performance recalls

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

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2023-03-22

Of the 10 reduced performance 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 reduced performance 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.

1–10 of 10

  • ModerateFDA (Devices)·Z-1251-2023·2023-03-22

    BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues

    BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2023·2023-03-22

    BioFire Respiratory Panel 2.1 Recalled Due to Temperature Shipping Excursions

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2023·2023-03-22

    In Vitro Diagnostic GI Panel Recalled Due to Temperature Exposure During Shipping

    BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.

    Product
    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2020·2019-11-20

    Orthofix Galaxy Wrist Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling Galaxy Wrist Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0386-2020·2019-11-20

    Orthofix Radiolucent Wrist Fixator Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0391-2020·2019-11-20

    Orthofix Prefix II Diaphyseal Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Prefix II Diaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0395-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix is recalling Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0387-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect

    Orthofix Srl is recalling UE Xcaliber Metadiaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0716-2018·2018-03-07

    Philips Recalls Allura Xper Systems Due to Anode Drive Unit Failure

    Philips is recalling 705 Allura Xper systems because Anode Drive Units may fail in high-voltage regions, reducing X-ray performance to emergency mode.

    Product
    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide