Smiths Medical Asd, Inc.
Also registered as Smith Medical Asd, Inc.
Country not established
- Devices
- 54
- FDA recalls
- 474140 ongoing since 2021 (143 open in total)
What Smiths Medical Asd, Inc. makes
Smiths Medical Asd, Inc. manufactures medical devices including pediatric and adult underbody warming blankets, closed blood collection systems with safety holders, heated humidifiers and ventilator breathing circuits, implantable venous access systems, needle safety devices, tracheostomy tubes, and arterial blood sampling systems.
The company’s portfolio includes devices regulated as Class I, Class II, and Class III under FDA requirements, with submissions recorded in the 510(k) and PMA registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 54 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Hypodermic Needle-Pro EDGE Safety Device Ref K211634
Regimes: 510(k) Registry: 510(k)Port-A-Cath(R) Epidural Implantable Access Syst Ref P900052
Regimes: PMA, withdrawn Registry: PMA
Showing 51-54 of 54
FDA recalls
FDA recall records list 474 recalls initiated by Smiths Medical Asd, Inc., the earliest on 2003-12-12 and the most recent on 2025-04-10. By recorded status: 143 ongoing, 328 terminated and 3 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 19
- 2018 15
- 2019 5
- 2020 25
- 2021 23
- 2022 8
- 2023 27
- 2024 83
- 2025 20
- 2026 0
2025
- 10 Apr 2025 Z-1662-2025 Class I Ongoing 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.
- 10 Apr 2025 Z-1667-2025 Class I Ongoing 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.
- 10 Apr 2025 Z-1668-2025 Class I Ongoing 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.
- 10 Apr 2025 Z-1681-2025 Class I Ongoing There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- 10 Apr 2025 Z-1682-2025 Class I Ongoing There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- 14 Feb 2025 Z-1404-2025 Class II Ongoing 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, cardiopulmonary collapse, or death.
- 14 Feb 2025 Z-1405-2025 Class II Ongoing 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, cardiopulmonary collapse, or death.
- 13 Feb 2025 Z-1277-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1278-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1279-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Show the 25 most recent of 474 recalls
2025
- 13 Feb 2025 Z-1280-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1281-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1282-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1283-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1284-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1285-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1286-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1287-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1288-2025 Class I Ongoing The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 13 Feb 2025 Z-1289-2025 Class I Ongoing 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.
2024
- 28 Oct 2024 Z-0527-2025 Class II Ongoing 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 addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 28 Oct 2024 Z-0528-2025 Class II Ongoing 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 addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 28 Oct 2024 Z-0529-2025 Class II Ongoing 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 addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- 24 Sep 2024 Z-0182-2025 Class II Ongoing 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.
- 24 Sep 2024 Z-0183-2025 Class II Ongoing 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.