CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report

medex TranStar Patient Mount Monitoring Kit 10/EA recalled

Smiths Medical ASD is recalling medex TranStar Patient Mount Monitoring Kit 10/EA. The recall was initiated on 24 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 50351688504072 (case), 10351688504074 (pouch), Lot Numbers: 4304896, 4346065, 4355385, 4376424

Quantity recalled1740 units

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-0189-2025
FDA event ID: 95438
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 24 Sep 2024
FDA classified: 23 Oct 2024
Reported: 30 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

24 Sep 2024	Recall initiated by company
23 Oct 2024	Classified by FDA	+29 days
30 Oct 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

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Product as listed by the FDA

medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 50351688504072 (case), 10351688504074 (pouch), Lot Numbers: 4304896, 4346065, 4355385, 4376424

Where was it sold?

Worldwide distribution.

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

23 other products · FDA event 95438

This product is part of a recall event; the main page for the event is medex Arterial Kit 1/EA recalled by Smiths Medical ASD.

Reported	Class	Recall	Company	Reason	Where
30 Oct 2024	CLASS II	medex Arterial Kit 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	smiths medical SurgiVet Advisor Tech Accessories recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar DPT w/Stopcock & 3cc Flush 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Stopcock w/Ext recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex Transtar Monitoring Kit 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar DPT w/Stopcock & 30cc Flush 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kids Kit Closed Blood Sample Kit recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kids Kit Closed Blood Sample Kit recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Monitoring Set W/Sampling Port 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kids Kit Closed Blood Sample Kit recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar DPT w/Two Stopcocks 10/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Single Monitoring Kit 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Single Monitoring Kit 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Single Set With Anti-shunt Stopcock 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Single ICP Set 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Single OR Set 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Double Monitoring Kit 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Neonatal Monitoring Kit 10/EA recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kit w/ Stopcock1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex NICU Monitoring Kit Set 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kids Kit Closed Blood Sample Kit recalled	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Disposable Transducer 1/EA recalled by Smiths Medical ASD	Smiths Medical ASD	Labeling Errors	MN
30 Oct 2024	CLASS II	medex TranStar Kids Kit Closed Blood Sample Kit recalled	Smiths Medical ASD	Labeling Errors	MN

More recalls from Smiths Medical ASD

All 284

Reported	Class	Recall	Company	Reason	Where
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

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide