Smiths Medical ASD Inc. recall records

138 reported ongoing

138 records in this archive. Latest source date Apr 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF ...
FDA device enforcement

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
FDA device enforcement

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Co...
FDA device enforcement

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

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 th...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Co...

Reasons in these listed records

  • Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In a...
  • 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 Disposabl...

These examples come from this result page and are not a ranking of every recall reason.

Checking Smiths Medical ASD Inc.

Is there a recall on smiths medical asd inc. right now?

This archive contains 138 records, including 138 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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