The Recall Desk
HighFDA (Devices)·Z-2072-2016·Announced 2016-07-06

Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel

Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Pentax Medical Company is recalling 1,220 units of Intubation Scopes. The affected models include FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS, and FI-9RBS. These devices are intended to provide optical visualization and therapeutic access to facilitate tracheal intubations in adult and pediatric patients.

The recall was initiated because Pentax became aware that operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel. This issue affects the device's ability to function as intended during procedures.

The recalled units were distributed nationwide in the United States, including Puerto Rico, and internationally to Denmark and Guam. Healthcare facilities and users should stop using the affected devices and contact Pentax Medical Company for instructions on how to proceed.

The recalled product

Product
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy / Intubation
Hazard
Affected units
1,220

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Model #'s FI-10BS
  • FI-10P2
  • FI-10RBS
  • FI-13BS
  • FI-13P
  • FI-13RBS
  • FI-16BS
  • FI-16RBS
  • FI-9BS and FI-9RBS

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 16 recalled by Pentax Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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