The Recall Desk

Hazard

Improper Bonding 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
2023-04-12

Of the 5 improper bonding 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 improper bonding 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-1347-2023·2023-04-12

    CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding

    Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.

    Product
    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2023·2023-04-12

    Terumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding

    Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were distributed across the US and internationally.

    Product
    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2023·2023-04-12

    CAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding

    Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.

    Product
    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2022·2022-07-20

    Dental bonding primer may lack resin component affecting restoration

    Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.

    Product
    Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2016·2015-12-30

    Terumo Recalls Winged Infusion Sets Due to Improper Bonding

    Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.

    Product
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
    Category
    Medical Device
    Distribution
    1 state