The Recall Desk
HighFDA (Devices)·Z-2368-2015·Announced 2015-08-26

Teleflex Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes Due to Connector Cracking

Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

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 structural defect (connector cracking/separation) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Teleflex Medical is recalling specific lots of the HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided). The affected sizes are 28 Fr., 35 Fr., 37 Fr., 39 Fr., and 41 Fr. These sterile, prescription-only devices are intended for use in thoracic surgery, bronchospirometry, and the administration of bronchial anesthesia.

The recall is being issued because the double swivel connector on the endobronchial tube may crack or separate. A total of 188,195 units are involved in this recall. The products were distributed nationwide in the United States and in the Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand, and Vietnam.

Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. Patients who have had these devices used should contact their healthcare provider if they have concerns.

The recalled product

Product
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring b
Manufacturer
Teleflex Medical
Category
Medical Device — Endobronchial Tubes
Hazard
Affected units
188,195

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 (20)

  • Product Code: 5-16128
  • Lot numbers: 73L1400012
  • 73K1400582
  • 73L1400233 and 73A1500039
  • Product Code: 5-16135
  • Lot numbers: 73B1500259
  • 73B1500293
  • 73C1500401
  • 73C1500426
  • 01K1300470
  • 01B1400479
  • 73D1400498
  • 73F1400096
  • 73H1400443
  • 73J1400117
  • 73K1400583
  • 73L1400094
  • 73A1500205
  • 73A1500206 and 73B1500258
  • Product Code: 5-16137

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teleflex Medical 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 4 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

See all →

Same hazard · structural defect

See all →