The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1127-2022·Announced 2022-06-01

Teleflex Breathing Tubes Recalled Due to Reports of Tearing

Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device recall involving respiratory equipment with structural defects (torn tubing). No injuries or illnesses have been reported, but the defect poses a risk of harm to respiratory function, meeting the criteria for a high-severity recall of risk-of-harm medical devices.

Plain-English summary

Teleflex Medical Inc is recalling four models of corrugated breathing tubes following reports of torn tubes. The recalled products include the Flex tube (Product #20011, sterile), Smooth-Flo Flex with Double Swivel (Products #22511 sterile and #22512 non-sterile), and Smooth-Flo Flex (Product #22552, non-sterile), with approximately 290,809 units affected.

The recall was initiated following reports of torn corrugated breathing tubes. These structural defects in the tubing material represent a potential risk to proper device function.

The affected devices were distributed worldwide, including throughout the United States and to multiple international locations including Canada, Australia, and several European countries. Specific batch and UDI numbers for the recalled units are available from the FDA.

The recalled product

Product
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Respiratory / Breathing Tubes
Hazard
Affected units
290,809

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)

  • KMH21F0394 (01)04026704388769(17)260528(10)KMH21F0394
  • KMH21F0395 (01)04026704388769(17)260528(10)KMH21F0395
  • KMH21F0412 (01)04026704388769(17)260528(10)KMH21F0412
  • KMH21H0094 (01)04026704388769(17)260728(10)KMH21H0094
  • KMH21H0095 (01)04026704388769(17)260728(10)KMH21H0095
  • KMH21H0096 (01)04026704388769(17)260728(10)KMH21H0096
  • KMH21H0110 (01)04026704388769(17)260728(10)KMH21H0110
  • KMH21H0112 (01)04026704388769(17)260728(10)KMH21H0112
  • KMH21J0109 (01)04026704388769(17)260828(10)KMH21J0109
  • KMH21J0110 (01)04026704388769(17)260828(10)KMH21J0110
  • KMH21J0118 (01)04026704388769(17)260828(10)KMH21J0118
  • KMH21J0121 (01)04026704388769(17)260828(10)KMH21J0121
  • KMH21J0124 (01)04026704388769(17)260828(10)KMH21J0124
  • KMH21K0302 (01)04026704388769(17)260928(10)KMH21K0302
  • KMH21K0303 (01)04026704388769(17)260928(10)KMH21K0303
  • KMH21K0306 (01)04026704388769(17)260928(10)KMH21K0306
  • KMH21K0307 (01)04026704388769(17)260928(10)KMH21K0307
  • KMH21K0308 (01)04026704388769(17)260928(10)KMH21K0308
  • KMH21K0320 (01)04026704388769(17)260928(10)KMH21K0320
  • KMH21K0341 (01)04026704388769(17)260928(10)KMH21K0341

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 2 recalled by TELEFLEX MEDICAL INC 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 2 products in this recall →

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