Use caution Medical device recall · FDA · Published March 31, 2021

Smiths Medical Tubing Recall: Insufficient Welds in High-Pressure Adaptors

Smiths Medical recalls specific lots of tubing with male luer lock adapters due to potential insufficient welds in high-pressure adaptors, which could lead to device failure during use.

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

🇺🇸 FDA recall #Z-1480-2021Medical device Smiths Medical ›

Use caution until it’s fixed

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

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 two specific lengths of tubing with male luer lock adapters used in blood pressure monitoring systems. The recall is because some units may have been made with weak welds that could cause the tubing to fail during use, potentially leading to inaccurate readings or device malfunction. Read more at govinfonow.com/recall/62866-smiths-medical-tubing-recall-insufficient-welds-in-high-pressure-adaptors.

Source Summary by GovInfoNow · govinfonow.com/recall/62866-smiths-medical-tubing-recall-insufficient-welds-in-high-pressure-adaptors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1480-2021

Cite this page

“Smiths Medical Tubing Recall: Insufficient Welds in High-Pressure Adaptors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62866-smiths-medical-tubing-recall-insufficient-welds-in-high-pressure-adaptors. Based on FDA recall #Z-1480-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1480-2021%22&limit=1).

The FDA announced on March 31, 2021, that Smiths Medical ASD Inc. is recalling tubing with male luer lock adapters due to potential insufficient or incomplete welds in related Medex components. The recall affects specific lots of these medical device parts distributed nationwide and internationally.

How to tell if you have it

Brand: Smiths Medical
Product: Tubing with male luer lock adapter (Component)
REF 601280, Lot Numbers: 3872300, 3946984
REF 601281, Lot Numbers: 3872301, 4024481

The hazard

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These items are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls include the Smiths Medical CADD Solis VIP Infusion Pump Recall for potential thermal damage (April 10, 2025), false alarm risk (April 10, 2025), and wireless connection alarms risk (April 10, 2025). Other recent recalls of similar products include the Hamilton Medical IntelliCuff Recall for cuff system leakage error risk (May 22, 2026), Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall for incorrect tubing assembly (May 12, 2026), and Merit Medical Allwell Angioplasty Pack Recall where the handle may detach during procedure (December 4, 2025).

How to tell if you have this one

Check for tubing with male luer lock adapters labeled as 76 cm (REF 601280) or 122 cm (REF 607281). Look for lot numbers 3872300, 3946984 for the 76 cm tubing or 3872301, 4024481 for the 122 cm tubing.

Brand
Smiths Medical
Category
Medical device

FDA recall event · 12 products

All 12 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
Terminated
Distribution
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Recall number	Product, codes & lots	Quantity
Z-1470-2021	LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.; Lot Numbers: 4005361, 4022743	200 devices
Z-1471-2021	Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.; Lot Numbers: 4031331	10 devices
Z-1472-2021	Left Heart Kit, Model Number M20268. for blood pressure monitoring.; Lot Numbers: 4002486, 4019146, 4036647	600 devices
Z-1473-2021	LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.; Lot Numbers: 3995542, 4002489, 4016473, 4048833,4069387	3740 devices
Z-1474-2021	Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.; Lot Numbers: 4007165	400 devices
Z-1475-2021	ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.; Lot Numbers: 3979813, 3982717, 4016454, 4024471	5540 devices
Z-1476-2021	Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.; a. Model Number MX1232MR, Lot Numbers: 4027757 b. Model Number MX1233MR, Lot Numbers: 4076456 c. Model Number MX1322MR, Lot Numbers: 3992363, 4011839 d. Model Number MX1333MR, Lot Numbers: 4016439	1380 units
Z-1477-2021	Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.; a. Model Number MX1431MR, Lot Numbers: 3995544 b. Model Number MX1431MRL, Lot Numbers: 3995545, 4011838, 4027758, 4033501, 4044959 c. Model Number MX4331R, Lot Numbers: 3971467, 3987918	3825 units
Z-1478-2021	HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.; Lot Numbers: 38801606	275 units
Z-1479-2021	HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.; a. Model Number MX496HP, Lot Numbers: 3952480, 3974771 b. Model Number MX497HP, Lot Numbers: 3949391, 3971003	8150 units
Z-1480-2021	Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.; a. REF 601280, Lot Numbers: 3872300, 3946984 b. REF 601281, Lot Numbers: 3872301, 4024481	11340 units
Z-1481-2021	Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.; Lot Number 3946994	500 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the tubing length and lot numbers to confirm if it is part of the recall.
Contact Manufacturer
Reach out to Smiths Medical for further assistance if you have the recalled tubing.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.” 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 terminated this recall 2 years after the firm started it.

Mar 31, 2021Firm started the recall
Apr 21, 2021FDA classified it Class II
Apr 28, 2021Published in FDA’s Enforcement Report
Mar 20, 2023FDA terminated the recall

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/62866-smiths-medical-tubing-recall-insufficient-welds-in-high-pressure-adaptors">Smiths Medical Tubing Recall: Insufficient Welds in High-Pressure Adaptors (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-1480-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1480-2021 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.