Lower risk Medical device recall · FDA · Published April 5, 2023

Smiths Medical DuraLife Swivel Elbow Recall: Inadequate Cleaning Instructions

Smiths Medical recalls DuraLife Autoclavable Double Swivel Elbows with suction ports due to insufficient cleaning and sterilization instructions, risking improper reuse on patients.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1580-2023Medical device Smiths Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

✎ GovInfoNow plain-language explainer

Smiths Medical is recalling DuraLife Autoclavable Double Swivel Elbows with suction ports because their cleaning and sterilization instructions are inadequate. This could lead to improper reuse on patients, potentially causing infections or other health risks. Read more at govinfonow.com/recall/58610-smiths-medical-duralife-swivel-elbow-recall-inadequate-cleaning-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/58610-smiths-medical-duralife-swivel-elbow-recall-inadequate-cleaning-instructions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1580-2023

Cite this page

“Smiths Medical DuraLife Swivel Elbow Recall: Inadequate Cleaning Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58610-smiths-medical-duralife-swivel-elbow-recall-inadequate-cleaning-instructions. Based on FDA recall #Z-1580-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1580-2023%22&limit=1).

The FDA announced on April 5, 2023, that Smiths Medical ASD Inc. is recalling DuraLife Autoclavable Double Swivel Elbow devices due to inadequate cleaning and sterilization instructions. The agency stated the recall is voluntary and affects products distributed worldwide.

How to tell if you have it

Brand: Smiths Medical
Product: DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port
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

The hazard

The FDA determined that the instructions for cleaning and sterilization for the DuraLife devices are inadequate. Specifically, the instructions do not provide the cleaning method, duration of the autoclave cycle, or specify the number of cycles the product can be reused on a single patient.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Smiths Medical CADD Solis VIP Infusion Pump Recall (April 10, 2025), Smiths Medical CADD-Solis HPCA Infusion Pump Recall (April 10, 2025), and Smiths Medical CADD Solis HSPCA Pump Recall (April 10, 2025).

How to tell if you have this one

Check for lot numbers: 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, and other numbers listed in the recall notice. These swivel elbows have suction ports and are used with breathing circuits.

Brand
Smiths Medical
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

Recall number	Product, codes & lots	Quantity
Z-1580-2023	DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits; 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	47007 units
Z-1581-2023	DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits; 3569291, 3802463, 3974741, 4093611, 4219069, 4340640, 3582651, 3832622, 4001787, 4108514, 4242510, 4340642, 3609721, 3871182, 4011956, 4116120, 4254340, 3609743, 3891814, 4032896, 4122394, 4264898, 3693349, 3914797, 4041943, 4151071, 4279831, 3723464, 3927549, 4063256, 4167796, 4290272, 3761125, 3952707, 4090324, 4182390, 4340638	2101 units
Z-1582-2023	DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits; Lot Numbers: 3572938, 3709023, 3917565, 4081673, 4176083, 4258736, 3582668, 3735447, 3936716, 4090325, 4176084, 4272705, 3602084, 3784974, 3974795, 4100952, 4187591, 4272706, 3617047, 3812333, 4011957, 4104648, 4207974, 4284609, 3623883, 3828394, 4029611, 4119019, 4207975, 4290273, 3631678, 3836006, 4038969, 4138936, 4220676, 4333910, 3662331, 3874536, 4063254, 4148601, 4242511, 4340649, 3688907, 3884430, 4067164, 4160298, 4254341, 4348704, 3693346, 3904854, 4076803, 4167797, 4258735	14941 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers listed in the recall notice to determine if your swivel elbow is affected.
Contact Manufacturer
Reach out to Smiths Medical for further guidance on the recall and potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

Apr 5, 2023Firm started the recall
May 12, 2023FDA classified it Class II
May 24, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58610-smiths-medical-duralife-swivel-elbow-recall-inadequate-cleaning-instructions">Smiths Medical DuraLife Swivel Elbow Recall: Inadequate Cleaning Instructions (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1580-2023 (April 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1580-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.