DuraLife Autoclavable Double Swivel Elbow — Class II medical device recall Z-1580-2023
Ongoing recall by Smiths Medical ASD Inc., reported 2023-05-24, distributed nationwide. DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifical
| Recall number | Z-1580-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2023-04-05 |
| Classified | 2023-05-12 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, NZ |
| Quantity | 47,007 units |
| Lot numbers | 3577218, 3582650, 3587542, 3596826, 3604794, 3613310, 3623879, 3627084, 3643070, 3671340, 3671341, 3673809, 3687267, 3690140, 3700821, 3709028, 3712265, 3723465, 3735446, 3738865, 3752126, 3761923, 3768558, 3768559, 3772121, 3779557, 3784957, 3788286, 3798095, 3802450, 3805780, 3819513, 3828396, 3836009, 3849849, 3863155, 3867378, 3880821, 3887812, 3901443 and 70 more |
| Model numbers | 60-0010 |
Product
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1580-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.