RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.
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: This is a risk-of-harm medical device (endotracheal tube used in critical airway management) with a functional defect that prevents proper verification of cuff inflation. However, no injuries or illnesses have been reported in the source text, placing it in the 'High' category per the FDA severity rubric.
Plain-English summary
Teleflex Medical Europe Ltd is recalling specific lots of RUSCH Endotracheal Tubes (High Volume, Low Pressure Cuff) distributed nationwide in the United States. A total of 2,610 units are affected across ten reference numbers.
The manufacturer received reports that the endotracheal tube cuff can be inflated while the pilot balloon remains flat. The pilot balloon is the standard indicator that the cuff has been properly inflated. If the pilot balloon fails to inflate while the cuff itself inflates, clinicians cannot verify whether the cuff is functioning correctly.
This recall affects healthcare facilities and medical professionals who use these tubes in airway management procedures. Affected lot numbers have been identified by the FDA. Healthcare providers should identify and quarantine any affected units and consult with Teleflex Medical Europe Ltd and the FDA for further instructions on inspection, return, or replacement.
The recalled product
- Product
- RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
- Manufacturer
- Teleflex Medical Europe Ltd
- Hazard
- cuff-malfunction
- pilot-balloon-failure
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)
- a) 112080050
- Lot Numbers: KME20K1512
- KME20L1145
- KME20M2383
- KME21B0357 b) 112080055
- Lot Numbers: KME20K2579
- KME21A2569
- KME21C1978 c) 112080060
- Lot Numbers: KME20M0616
- KME20M2112
- KME21A2685 d) 112080065
- Lot Numbers: KME20K2581
- KME21C1701 e) 112080070
- Lot Numbers: KME20K2577
- KME20L1985
- KME20M1771
- KME20M1772
- KME20M2856
- KME21A2355
- KME21B1624
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits recalled for defective Lidocaine Ampules
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided catheters recalled for packaging
FDA (Devices) · 2026-07-08
- SevereThyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination
FDA (Devices) · 2026-07-08