Recall Register

Device recall: medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

Class II FDA enforcement event 95438. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Smiths Medical ASD, Inc. started this device recall on 24 Sep 2024. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 95438 has 24 product records. The first FDA enforcement report date is 30 Oct 2024. The record gives the status Ongoing.

FDA enforcement reportThe 24 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide distribution.

Recalling firm

Smiths Medical ASD, Inc., Minneapolis, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

24 product records in the event.

FDA event 95438: product records
Recall numberProductQuantityClassStatusReport date
Z-0182-2025medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2260 unitsClass IIOngoing30 Oct 2024
Z-0183-2025medex TranStar Single ICP Set 1/EA, Product Code REF MX20897100 unitsClass IIOngoing30 Oct 2024
Z-0184-2025medex NICU Monitoring Kit Set 1/EA, Product Code REF MX2008650 unitsClass IIOngoing30 Oct 2024
Z-0185-2025medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1400 unitsClass IIOngoing30 Oct 2024
Z-0186-2025medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740260 unitsClass IIOngoing30 Oct 2024
Z-0187-2025medex Arterial Kit 1/EA, Product Code REF MX78272232 unitsClass IIOngoing30 Oct 2024
Z-0188-2025medex TranStar Disposable Transducer 1/EA, Product Code REF MX9501100 unitsClass IIOngoing30 Oct 2024
Z-0189-2025medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T1740 unitsClass IIOngoing30 Oct 2024
Z-0190-2025medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T6590 unitsClass IIOngoing30 Oct 2024
Z-0191-2025medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T5880 unitsClass IIOngoing30 Oct 2024
Z-0192-2025medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T1160168 unitsClass IIOngoing30 Oct 2024
Z-0193-2025medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT10 unitsClass IIOngoing30 Oct 2024
Z-0194-2025medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT1000 unitsClass IIOngoing30 Oct 2024
Z-0195-2025medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC1110 unitsClass IIOngoing30 Oct 2024
Z-0196-2025medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T2580 unitsClass IIOngoing30 Oct 2024
Z-0197-2025medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543800 unitsClass IIOngoing30 Oct 2024
Z-0198-2025medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544900 unitsClass IIOngoing30 Oct 2024
Z-0199-2025medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545250 unitsClass IIOngoing30 Oct 2024
Z-0200-2025medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX95473280 unitsClass IIOngoing30 Oct 2024
Z-0201-2025medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX95483490 unitsClass IIOngoing30 Oct 2024
Z-0202-2025medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242380 unitsClass IIOngoing30 Oct 2024
Z-0203-2025medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R13080 unitsClass IIOngoing30 Oct 2024
Z-0204-2025medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG3002601640 unitsClass IIOngoing30 Oct 2024
Z-0205-2025smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714N/AClass IIOngoing30 Oct 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024
970
Share of these events in Class II
87%
Product records in this event
24Median of the firm: 1
Events of the firm on the register
108

Other events of the firm

Other FDA enforcement events of Smiths Medical ASD, Inc.
InitiatedProduct (first record)TypeClassRecords
10 Apr 2025CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. DeviceClass I1
10 Apr 2025CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51DeviceClass I2
10 Apr 2025CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR DeviceClass I2
14 Feb 2025CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100DeviceClass II2
13 Feb 2025smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24DeviceClass I12
13 Feb 2025Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035DeviceClass I1
28 Oct 2024smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JPDeviceClass II3
18 Jul 2024smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWDeviceClass II5
16 Jul 2024CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD SDeviceClass I1
26 Jun 2024CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24DeviceClass II9

Smiths Medical ASD, Inc.: all 108 events

Official channels

Cite this page

Recall Register. FDA enforcement event 95438. https://recallregister.com/fda/ii/95438/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide distribution.
What quantity of product is in FDA event 95438?
The event has 24 product records. The first record gives this quantity: 260 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?
87% of the 970 device events that started in 2024 are in Class II.