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

CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PU...

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers usin...
FDA device enforcement

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD S...

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Class IReported ongoing

Distribution: Worldwide - US nationwide distribution.

Official source for CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO C...
FDA device enforcement

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-...

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Class IReported ongoing

Distribution: Worldwide - US nationwide distribution.

Official source for CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-01...
FDA device enforcement

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ven...

Class IIReported ongoing

Distribution: US Nationwide distribution. International distribution pending.

Official source for CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA device enforcement

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ven...

Class IIReported ongoing

Distribution: US Nationwide distribution. International distribution pending.

Official source for CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA device enforcement

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Class IReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Cat...
FDA device enforcement

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Class IReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Cat...
FDA device enforcement

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Class IReported ongoing

Distribution: Worldwide distribution.

Official source for smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, ...
FDA device enforcement

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/...

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Class IReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 ...

Reasons in these listed records

  • Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
  • Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
  • There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
  • Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, car...

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.

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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.

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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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