# FDA recall Z-1127-2022

> **TELEFLEX MEDICAL INC** · Class II · device recall initiated 2022-04-11.

## 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.

## Reason for recall

Reports received of torn corrugated breathing tubes.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.

## Key facts

- **Recall number:** Z-1127-2022
- **Recalling firm:** TELEFLEX MEDICAL INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-11
- **Report date:** 2022-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2022

## Citation

> AI Analytics. FDA recall Z-1127-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1127-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*