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Use caution Medical device recall · FDA · Published September 24, 2024

Smiths Medical Arterial Kit Recall: Inaccurate Pressure Monitoring Risk

Smiths Medical recalls medex Arterial Kit 1/EA with Product Code REF MX7827 due to potential inaccurate pressure monitoring. Affected units may have leaks or defects in the TranStar Disposable Pressure Transducer.

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

🇺🇸 FDA recall #Z-0187-2025Medical deviceSmiths Medical ›
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Contact the company

Recalling firmSmiths Medical ASD, Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer

Smiths Medical is recalling its medex Arterial Kit 1/EA (Product Code REF MX7827) because a manufacturing defect could cause inaccurate pressure readings or interruptions in monitoring. This risk is serious for medical use, as incorrect pressure measurements could lead to improper treatment decisions. Read more at govinfonow.com/recall/53865-smiths-medical-arterial-kit-recall-inaccurate-pressure-monitoring-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53865-smiths-medical-arterial-kit-recall-inaccurate-pressure-monitoring-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0187-2025

Cite this page

“Smiths Medical Arterial Kit Recall: Inaccurate Pressure Monitoring Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53865-smiths-medical-arterial-kit-recall-inaccurate-pressure-monitoring-risk. Based on FDA recall #Z-0187-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2025%22&limit=1).

The FDA announced on September 24, 2024, that Smiths Medical ASD, Inc. is recalling the medex Arterial Kit due to a manufacturing defect causing inaccurate or interrupted pressure monitoring. The agency issued recall number Z-0187-2025 for the Class II device distributed worldwide.

How to tell if you have it

  • Brand: Smiths Medical
  • Product: medex Arterial Kit 1/EA
  • Product Code: REF MX7827
  • Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161

The hazard

According to the FDA, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device. These issues stem from a leak within the TranStar Disposable Pressure Transducer or a defect within its chip.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has issued 73 other recalls since June 5, 2017. Recent Smiths Medical recalls include the CADD-Solis VIP Infusion Pump on April 10, 2025, and the CADD Solis HSPCA Pump on the same date. Other recent recalls of similar products include the Hamilton Medical IntelliCuff (May 22, 2026), AVID Medical Halyard Arteriogram (November 14, 2025), and Windstone Aligned Medical AMS16835 Fluids Kit (April 27, 2026).

How to tell if you have this one

Check for Product Code REF MX7827 on the kit. Lot numbers 4282733, 4319605, 4340472, 4355338, 4390060, or 4411161 are affected. The kit includes a case with UDI/DI 50351688505185 and a pouch with UDI/DI 10351688505187.

  • Brand
    Smiths Medical
  • Category
    Medical device
FDA recall event · 24 products

All 24 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.
Recall numberProduct, codes & lotsQuantity
Z-0182-2025medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2; UDI/DI 50351688508780 (case), 10351688508782 (pouch) , Lot Numbers: 4282732, 4287721260 units
Z-0183-2025medex TranStar Single ICP Set 1/EA, Product Code REF MX20897; UDI/DI 50351688508551 (case), 10351688508553 (pouch), Lot Numbers: 4323116100 units
Z-0184-2025medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086; UDI/DI 50351688509817 (case), 10351688509819 (pouch), Lot Numbers: 427011750 units
Z-0185-2025medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1; UDI/DI 50351688551694 (case), 10351688551696 (pouch), Lot Numbers: 4270117400 units
Z-0186-2025medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740; UDI/DI 50351688508957 (case), 10351688508959 (pouch), Lot Numbers: 4273609260 units
Z-0187-2025medex Arterial Kit 1/EA, Product Code REF MX7827; UDI/DI 50351688505185 (case), 10351688505187 (pouch), Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 44111612232 units
Z-0188-2025medex TranStar Disposable Transducer 1/EA, Product Code REF MX950; UDI/DI 50351688504126 (case), 10351688504128 (pouch), Lot Numbers: 4293125, 4328466, 4277644, 4349995, 43632551100 units
Z-0189-2025medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T; UDI/DI 50351688504072 (case), 10351688504074 (pouch), Lot Numbers: 4304896, 4346065, 4355385, 43764241740 units
Z-0190-2025medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T; UDI/DI 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 42876336590 units
Z-0191-2025medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T; UDI/DI 50351688504034 (case), 10351688504036 (pouch), Lot Numbers: 4277662, 4287634, 42894055880 units
Z-0192-2025medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T; UDI/DI 50351688503990 (case), 10351688503992 (pouch), Lot Numbers: 4277670, 4287645, 4287649, 4299776, 4277696, 4308930, 4299811, 4308934, 4299812, 4323148, 4264943, 4264939, 4277694, 4264950, 4299779, 4308962, 4323175, 4328515, 4299788, 4299789, 4299790, 4299801, 4299802, 4308954, 4308959, 4308963, 4321917, 4308947, 4334499, 4299786, 4355732, 4355735, 4346115, 4299780, 4355730, 4355727, 4334501, 4346096, 4346097, 4346124, 4355733, 4346109, 4355728, 4355740, 4355750, 4355749, 4355746, 4346120, 4355757, 43557531160168 units
Z-0193-2025medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT; UDI/DI 50351688503945 (case), 10351688503947 (pouch), Lot Numbers: 427766310 units
Z-0194-2025medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT; UDI/DI 50351688503938 (case), 10351688503930 (pouch), Lot Numbers: 4293126, 4309186, 4316649, 4323123, 4328467,43460491000 units
Z-0195-2025medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC; UDI/DI 50351688503921 (case), 10351688503923 (pouch), Lot Numbers: 4363257, 43857601110 units
Z-0196-2025medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T; UDI/DI 50351688503280 (case), 10351688503282 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 43668812580 units
Z-0197-2025medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543; UDI/DI 50351688503099 (case), 10351688503091 (pouch), Lot Numbers: 4297925, 4340497, 4355387800 units
Z-0198-2025medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544; UDI/DI 50351688503082 (case), 10351688503084 (pouch), Lot Numbers: 4226214, 4346067, 4350021, 4359831900 units
Z-0199-2025medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545; UDI/DI 50351688503068 (case), 10351688503060 (pouch), Lot Numbers: 4323136250 units
Z-0200-2025medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547; UDI/DI 50351688503013 (case), 10351688503015 (pouch), Lot Numbers: 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, 43500223280 units
Z-0201-2025medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548; UDI/DI 50351688503006 (case), 10351688503008 (pouch), Lot Numbers: 4221225, 4250996, 4297929, 4304897,4316671, 4323138, 4328494, 4387189, 44047133490 units
Z-0202-2025medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242; UDI/DI 50351688517782 (case), 10351688517784 (pouch), Lot Numbers: 4346040, 4385749, 4400278, 4440647380 units
Z-0203-2025medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1; UDI/DI 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 43668813080 units
Z-0204-2025medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260; UDI/DI 50351688518833 (case), 10351688518835 (pouch), Lot Numbers: 4270120, 4297963, 4316640, 4319604, 4323118, 4287727, 4359814, 4387976, 43404731640 units
Z-0205-2025smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714; UDI/DI N/A, Lot Numbers: 6000465, 6000466N/A
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Verify the Product Code REF MX7827 and Lot Numbers 4282733, 4319605, 4340472, 4355338, 4390060, or 4411161 to confirm if your kit is affected.

How this recall unfolded

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Sep 24, 202412. FDA classified it Class II: Oct 23, 202423. Published in FDA’s Enforcement Report: Oct 30, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0187-2025 (September 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0187-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA