DuraLife Breathing Circuit Extension Tube Recall Due to Inadequate Sterilization Instructions
Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.
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 an FDA Class II medical device recall without reported hospitalizations or injuries. The hazard—inadequate sterilization instructions that could lead to improper decontamination—represents a risk of harm where no injury has yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Smiths Medical ASD Inc. is recalling 2,101 units of the DuraLife Autoclavable Silicone Extension Tube (REF 60-1502, UltraSet Product Code 66-2509), a Non-Ported Double Swivel Elbow component used with breathing circuits.
The recall was issued because the Instructions for Use (IFU) are inadequate. Specifically, the instructions do not provide the cleaning method, do not specify the duration of the autoclave sterilization cycle, and do not specify how many times the product can be reused on a single patient. These missing specifications create a risk that healthcare facilities may improperly sterilize or reuse the devices, potentially leading to inadequate decontamination and infection risk.
The recalled devices were distributed worldwide, including the United States nationwide and to Canada, New Zealand, and Hong Kong. Affected lot codes are listed in the FDA recall notice.
Healthcare providers and facilities using these devices should immediately contact Smiths Medical ASD Inc. for clarified sterilization instructions or replacement devices. Devices should not be used until adequate sterilization instructions are available.
The recalled product
- Product
- DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- improper-sterilization
- infection-risk
- inadequate-instructions
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)
- 3569291
- 3802463
- 3974741
- 4093611
- 4219069
- 4340640
- 3582651
- 3832622
- 4001787
- 4108514
- 4242510
- 4340642
- 3609721
- 3871182
- 4011956
- 4116120
- 4254340
- 3609743
- 3891814
- 4032896
Distribution
Distributed nationwide across the United States.
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