The Recall Desk

Hazard

Unapproved Device recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved device 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.

1–25 of 135

  • ModerateFDA (Devices)·Z-2271-2026·2026-06-10

    Covidien esophageal stethoscope temperature sensors lack FDA clearance

    Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.

    Product
    Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2026·2026-06-10

    Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance

    Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 units are affected.

    Product
    Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2272-2026·2026-06-10

    Covidien Mon-a-Therm general purpose temperature probes lack FDA clearance

    Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.

    Product
    Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2026·2026-05-13

    One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step pH in vitro diagnostic test REF: 31I4P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2026·2026-05-13

    One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.

    Product
    One Step 10A in vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2087-2026·2026-05-13

    One Step K in vitro diagnostic test recall for missing FDA clearance

    DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.

    Product
    One Step K in vitro diagnostic test REF: 81A4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide