Flexicare Medical Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0497-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers

Product Classification:

Class I

Date Initiated: September 22, 2020

Date Posted: December 2, 2020

Recall Number: Z-0497-2021

Event ID: 86484

Reason for Recall:

When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

Status: Terminated

Product Quantity: 2087

Code Information:

Part/ Lot: 038-990-080U/ 191102901, 200300486, 200300539, 200500068, 200500069, 200803210, 191201567, 200904316, 200904319; 038-990-075U/ 191102900, 200100157, 200300535, 200300536, 200300537, 200402330, 200402331, 200402333, 200402334, 200402335, 200402336, 200402337, 200403976, 200404287, 200500991, 200500992, 200501790; 038-990-070U/ 201000813, 201100558; 038-990-065U/ 201000808, 202002462 *Note: product and lot number list updated per 12/23/2020 letter to customers

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated