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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95438

24 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 24, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

24 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 24

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

Z-0182-2025
Recall number
Z-0182-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
260 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688508780 (case), 10351688508782 (pouch) , Lot Numbers: 4282732, 4287721

Distribution pattern

Worldwide distribution.

device · product 2 of 24

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

Z-0183-2025
Recall number
Z-0183-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
100 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688508551 (case), 10351688508553 (pouch), Lot Numbers: 4323116

Distribution pattern

Worldwide distribution.

device · product 3 of 24

medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086

Z-0184-2025
Recall number
Z-0184-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
50 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688509817 (case), 10351688509819 (pouch), Lot Numbers: 4270117

Distribution pattern

Worldwide distribution.

device · product 4 of 24

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

Z-0185-2025
Recall number
Z-0185-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
400 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688551694 (case), 10351688551696 (pouch), Lot Numbers: 4270117

Distribution pattern

Worldwide distribution.

device · product 5 of 24

medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740

Z-0186-2025
Recall number
Z-0186-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
260 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688508957 (case), 10351688508959 (pouch), Lot Numbers: 4273609

Distribution pattern

Worldwide distribution.

device · product 6 of 24

medex Arterial Kit 1/EA, Product Code REF MX7827

Z-0187-2025
Recall number
Z-0187-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
2232 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688505185 (case), 10351688505187 (pouch), Lot Numbers: 4282733, 4319605, 4340472, 4355338, 4390060, 4411161

Distribution pattern

Worldwide distribution.

device · product 7 of 24

medex TranStar Disposable Transducer 1/EA, Product Code REF MX950

Z-0188-2025
Recall number
Z-0188-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1100 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688504126 (case), 10351688504128 (pouch), Lot Numbers: 4293125, 4328466, 4277644, 4349995, 4363255

Distribution pattern

Worldwide distribution.

device · product 8 of 24

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

Z-0189-2025
Recall number
Z-0189-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1740 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide distribution.

device · product 9 of 24

medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

Z-0190-2025
Recall number
Z-0190-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
6590 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688504041 (case), 10351688504043 (pouch), Lot Numbers: 4270150, 4277661, 4277716, 4287633

Distribution pattern

Worldwide distribution.

device · product 10 of 24

medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

Z-0191-2025
Recall number
Z-0191-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
5880 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688504034 (case), 10351688504036 (pouch), Lot Numbers: 4277662, 4287634, 4289405

Distribution pattern

Worldwide distribution.

device · product 11 of 24

medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

Z-0192-2025
Recall number
Z-0192-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1160168 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 4355753

Distribution pattern

Worldwide distribution.

device · product 12 of 24

medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

Z-0193-2025
Recall number
Z-0193-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
10 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503945 (case), 10351688503947 (pouch), Lot Numbers: 4277663

Distribution pattern

Worldwide distribution.

device · product 13 of 24

medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT

Z-0194-2025
Recall number
Z-0194-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1000 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503938 (case), 10351688503930 (pouch), Lot Numbers: 4293126, 4309186, 4316649, 4323123, 4328467,4346049

Distribution pattern

Worldwide distribution.

device · product 14 of 24

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

Z-0195-2025
Recall number
Z-0195-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1110 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503921 (case), 10351688503923 (pouch), Lot Numbers: 4363257, 4385760

Distribution pattern

Worldwide distribution.

device · product 15 of 24

medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T

Z-0196-2025
Recall number
Z-0196-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
2580 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503280 (case), 10351688503282 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881

Distribution pattern

Worldwide distribution.

device · product 16 of 24

medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

Z-0197-2025
Recall number
Z-0197-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
800 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503099 (case), 10351688503091 (pouch), Lot Numbers: 4297925, 4340497, 4355387

Distribution pattern

Worldwide distribution.

device · product 17 of 24

medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

Z-0198-2025
Recall number
Z-0198-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
900 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503082 (case), 10351688503084 (pouch), Lot Numbers: 4226214, 4346067, 4350021, 4359831

Distribution pattern

Worldwide distribution.

device · product 18 of 24

medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

Z-0199-2025
Recall number
Z-0199-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
250 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503068 (case), 10351688503060 (pouch), Lot Numbers: 4323136

Distribution pattern

Worldwide distribution.

device · product 19 of 24

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

Z-0200-2025
Recall number
Z-0200-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
3280 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503013 (case), 10351688503015 (pouch), Lot Numbers: 4223699, 4248326, 4297927, 4323137, 4340498, 4346068, 4350022

Distribution pattern

Worldwide distribution.

device · product 20 of 24

medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

Z-0201-2025
Recall number
Z-0201-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
3490 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688503006 (case), 10351688503008 (pouch), Lot Numbers: 4221225, 4250996, 4297929, 4304897,4316671, 4323138, 4328494, 4387189, 4404713

Distribution pattern

Worldwide distribution.

device · product 21 of 24

medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242

Z-0202-2025
Recall number
Z-0202-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
380 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688517782 (case), 10351688517784 (pouch), Lot Numbers: 4346040, 4385749, 4400278, 4440647

Distribution pattern

Worldwide distribution.

device · product 22 of 24

medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

Z-0203-2025
Recall number
Z-0203-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
3080 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688518123 (case), 10351688518125 (pouch), Lot Numbers: 4282765, 4307302, 4309198, 4311461, 4316668, 4328487, 4350011, 4366881

Distribution pattern

Worldwide distribution.

device · product 23 of 24

medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

Z-0204-2025
Recall number
Z-0204-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
1640 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 50351688518833 (case), 10351688518835 (pouch), Lot Numbers: 4270120, 4297963, 4316640, 4319604, 4323118, 4287727, 4359814, 4387976, 4340473

Distribution pattern

Worldwide distribution.

device · product 24 of 24

smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

Z-0205-2025
Recall number
Z-0205-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI N/A, Lot Numbers: 6000465, 6000466

Distribution pattern

Worldwide distribution.