CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report
DuraLife Autoclavable Double Swivel Elbow recalled by Smiths Medical ASD
Smiths Medical ASD is recalling DuraLife Autoclavable Double Swivel Elbow, distributed nationwide in the US. The recall was initiated on 5 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1580-2023
- FDA event ID
- 91975
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Apr 2023
- FDA classified
- 12 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2023 | Recall initiated by company | |
| 12 May 2023 | Classified by FDA | +37 days |
| 24 May 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
Questions about this recall
Why was it recalled?
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Which lots are affected?
Lot Numbers: 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, 3582650, 3752126, 3901443, 4029610, 4153964, 4258734, 3587542, 3761923, 3911867, 4038968, 4164878, 4264897, 3596826, 3768558, 3914813, 4041942, 4173946, 4269655, 3604794, 3768559, 3917564, 4063257, 4176082, 4279829, 3613310, 3772121, 3931273, 4063258, 4182389, 4279830, 3623879, 3779557, 3933681, 4067165, 4187590, 4284606, 3627084, 3784957, 3936715, 4072088, 4192791, 4284607, 3643070, 3788286, 3942733, 4076804, 4201183, 4290269, 3671340, 3798095, 3952706, 4081672, 4204667, 4290270, 3671341, 3802450, 3956054, 4086259, 4215512, 4318561, 3673809, 3805780, 3959458, 4090323, 4219068, 4335149, 3687267, 3819513, 3970976, 4093610, 4229475, 4335150, 3690140, 3828396, 3974773, 4104647, 4242508, 4337436, 3700821, 3836009, 3988375, 4108513, 4242509, 4361916, 3709028, 3849849, 4001786, 4111190, 4247925, 3712265, 3863155, 4005980, 4116119, 4247926, 3723465, 3867378, 4011955, 4132044, 4254339, 3735446, 3880821, 4018725, 4138935, 4258732
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 91975| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DuraLife Autoclavable Silicone Extension Tube recalled | Smiths Medical ASD | Sterility | Nationwide | |
| CLASS II | DuraLife Autoclavable Silicone Extension Tube recalled | Smiths Medical ASD | Sterility | Nationwide |
More recalls from Smiths Medical ASD
All 284| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Cadd Solis Hspca Pump ***Updated 5/27/26*** Scope updated recalled | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |