Smiths Medical Asd, Inc.
Country not established
- Devices
- 54
- FDA recalls
- 474140 ongoing
At a glance
Market reach
- United States
- FDA recalls
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 devicesShowing 1-50 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.
Frequently asked questions
How many devices does Smiths Medical Asd, Inc. have in the registry?
The registry currently lists 54 devices for Smiths Medical Asd, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smiths Medical Asd, Inc.'s devices?
Among its 50 most recently registered devices, Smiths Medical Asd, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Smiths Medical Asd, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Smiths Medical Asd, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smiths Medical Asd, Inc.?
FDA recall records list 474 recalls initiated by Smiths Medical Asd, Inc., the most recent initiated on 2025-04-10. 143 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Smiths Medical Asd, Inc. in the registry?
The most recently registered devices listed for Smiths Medical Asd, Inc. include LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH, THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS and PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS.