CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

Inj Line Rotating Adapt (900psi), List Number MX694R recalled

Smiths Medical Asd is recalling Inj Line Rotating Adapt (900psi), List Number MX694R, distributed nationwide in the US. The recall was initiated on 10 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 4383431 4387987 4404698

Quantity recalled31,685 total

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-0747-2024
FDA event ID: 93506
Recalling firm: Smiths Medical Asd, Dublin, OH
Classification: Class II
Status: Ongoing
Recall initiated: 10 Nov 2023
FDA classified: 17 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

10 Nov 2023	Recall initiated by company
17 Jan 2024	Classified by FDA	+68 days
24 Jan 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: 4383431 4387987 4404698

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

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

8 other products · FDA event 93506

Reported	Class	Recall	Company	Reason	Where
24 Jan 2024	CLASS II	Medex Inj Line Rotating Adapt, List Number MX682R recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	1050 Stopcock Left Rotator Off Handle, List Number MX1431MRL recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	High Pressure Rotator With Male Luer Lock, List Number MX496HP recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	High Pressure Rotator With Female Luer Lock, List Number MX497HP recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	Pressure Tubing, List Number MX20617 recalled by Smiths Medical Asd	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	Medex Logical Cath Lab Kit, List Number M20754 recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	Braided Inj Line, Rotating Adapt, List Number MX682BR recalled	Smiths Medical Asd	Packaging Defects	Nationwide
24 Jan 2024	CLASS II	Medex 700PSI Stopcock W/Rotator, List Number MX4331R recalled	Smiths Medical Asd	Packaging Defects	Nationwide

More recalls from Smiths Medical Asd

All 284

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14 May 2025Device	CLASS I	Cadd Solis Hspca Pump *Updated 5/27/26* Scope updated recalled	Smiths Medical ASD	Device Malfunction	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide