Smiths Medical ASD, Inc.: FDA recalls

FDA enforcement reports name Smiths Medical ASD, Inc. as the recalling firm in 108 events. The events have 293 product records. The recalls started from 2010 to 2025. All the events are device recalls.

See the 108 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

108 events, newest first.

FDA enforcement events of Smiths Medical ASD, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
10 Apr 2025	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: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH,…	Device	Class I	1	Ongoing
10 Apr 2025	CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT,…	Device	Class I	2	Ongoing
10 Apr 2025	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 SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR…	Device	Class I	2	Ongoing
14 Feb 2025	CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100	Device	Class II	2	Ongoing
13 Feb 2025	smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24	Device	Class I	12	Ongoing
13 Feb 2025	Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035	Device	Class I	1	Ongoing
28 Oct 2024	smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP	Device	Class II	3	Ongoing
24 Sep 2024	medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2	Device	Class II	24	Ongoing
18 Jul 2024	smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f)…	Device	Class II	5	Ongoing
16 Jul 2024	CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238,…	Device	Class I	1	Ongoing
26 Jun 2024	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24	Device	Class II	9	Ongoing
26 Jun 2024	smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps	Device	Class II	1	Ongoing
7 Jun 2024	smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN,…	Device	Class I	3	Ongoing
31 May 2024	Pneupac paraPAC plus 300 ventilator kit, REF P300NXX	Device	Class I	2	Ongoing
31 May 2024	paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N	Device	Class I	2	Ongoing
29 May 2024	PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180	Device	Class I	28	Ongoing
27 Feb 2024	CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion,…	Device	Class I	3	Ongoing
7 Feb 2024	smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS	Device	Class I	2	Ongoing
19 Dec 2023	smiths medical Medfusion Model 4000 syringe pump	Device	Class I	1	Ongoing
19 Dec 2023	smiths medical Medfusion Model 3500 Syringe pump	Device	Class I	1	Ongoing
19 Dec 2023	Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500	Device	Class II	4	Ongoing
10 Nov 2023	Medex LOGICAL CATH LAB KIT, List Number M20754	Device	Class II	9	Ongoing
6 Sep 2023	Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1	Device	Class II	1	Ongoing
22 Aug 2023	Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.	Device	Class II	1	Ongoing
16 Aug 2023	Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6	Device	Class II	6	Ongoing
18 Jul 2023	PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter	Device	Class II	1	Ongoing
5 Apr 2023	DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits	Device	Class II	3	Ongoing
9 Dec 2022	CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24	Device	Class I	5	Ongoing
10 Oct 2022	Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs,…	Device	Class II	1	Ongoing
18 Apr 2022	Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231	Device	Class I	2	Ongoing
9 Aug 2021	Bivona Aire-Cuf Endotracheal Tube	Device	Class II	2	Terminated
6 Aug 2021	NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129	Device	Class I	2	Ongoing
4 Aug 2021	smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.	Device	Class II	1	Terminated
15 Jul 2021	Pneupac paraPac plus 300 ventilator kit, REF P300NGB	Device	Class III	1	Terminated
17 May 2021	JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1	Device	Class I	1	Terminated
14 May 2021	PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.	Device	Class II	1	Terminated
31 Mar 2021	LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.	Device	Class II	12	Terminated
31 Mar 2021	Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.	Device	Class II	2	Terminated
18 Jan 2021	Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient…	Device	Class II	1	Terminated
21 Dec 2020	Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.	Device	Class II	1	Terminated
15 Dec 2020	PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45	Device	Class II	1	Terminated
8 Dec 2020	smiths medical portex Loss of Resistance Device, REF 100/398/000	Device	Class II	1	Terminated
28 Aug 2020	Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.	Device	Class II	1	Terminated
14 Jul 2020	CADD Administration Sets, Model #21-7346-24	Device	Class II	1	Terminated
26 Jun 2020	Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1	Device	Class I	2	Ongoing
11 Jun 2020	PORT-A-CATH II POWER P.A.C. Low Profile" system.	Device	Class II	1	Terminated
26 May 2020	Pediatric Adjustable Flange Tracheostomy Tube Cuffless	Device	Class II	1	Terminated
24 Mar 2020	CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n.…	Device	Class I	1	Terminated
10 Mar 2020	medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1	Device	Class II	12	Terminated
28 Feb 2020	Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with…	Device	Class II	1	Terminated
7 Jan 2020	Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes	Device	Class II	2	Terminated
28 Oct 2019	Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.	Device	Class I	1	Terminated
8 Jul 2019	GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X…	Device	Class II	2	Terminated
11 Feb 2019	Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.	Device	Class II	1	Terminated
11 Feb 2019	Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.	Device	Class II	1	Terminated
26 Nov 2018	ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.	Device	Class II	1	Terminated
19 Nov 2018	Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.	Device	Class II	1	Terminated
15 Oct 2018	Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000…	Device	Class II	1	Terminated
22 Aug 2018	Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the…	Device	Class II	1	Terminated
13 Jul 2018	Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.	Device	Class III	1	Terminated
6 Jul 2018	smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.	Device	Class III	5	Terminated
22 Jun 2018	Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509,…	Device	Class II	2	Terminated
10 May 2018	medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE	Device	Class II	1	Terminated
13 Apr 2018	Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism	Device	Class II	1	Terminated
2 Apr 2018	Bivona Tracheostomy Tube Tracheostomy Tubes	Device	Class II	1	Terminated
4 Dec 2017	PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)	Device	Class II	2	Terminated
29 Nov 2017	BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR,…	Device	Class II	1	Terminated
22 Nov 2017	CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY	Device	Class II	1	Terminated
13 Nov 2017	Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following…	Device	Class II	3	Terminated
25 Sep 2017	CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and…	Device	Class II	3	Terminated
24 Aug 2017	Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion	Device	Class II	1	Terminated
22 Aug 2017	Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics,…	Device	Class II	2	Terminated
14 Aug 2017	UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no…	Device	Class II	1	Terminated
5 Jun 2017	CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.	Device	Class II	1	Terminated
15 May 2017	CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.	Device	Class II	1	Terminated
4 Apr 2017	Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.	Device	Class II	1	Terminated
17 Mar 2017	CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.	Device	Class II	1	Terminated
9 Feb 2017	Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.	Device	Class II	1	Terminated
9 Dec 2016	Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.	Device	Class II	1	Terminated
21 Nov 2016	Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVC’s are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN)…	Device	Class II	1	Terminated
31 Oct 2016	CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,	Device	Class II	1	Terminated
31 Oct 2016	HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.	Device	Class III	1	Terminated
25 Oct 2016	NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a…	Device	Class II	1	Terminated
15 Jul 2016	Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.	Device	Class II	1	Terminated
22 Apr 2016	CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01,…	Device	Class II	1	Terminated
3 Dec 2015	Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.	Device	Class II	1	Ongoing
14 Sep 2015	PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.	Device	Class II	1	Terminated
26 May 2015	CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.	Device	Class II	1	Terminated
4 May 2015	Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.	Device	Class II	1	Terminated
21 Mar 2015	Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.	Device	Class II	1	Terminated
2 Feb 2015	CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.	Device	Class II	1	Terminated
17 Dec 2014	Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites,…	Device	Class III	1	Terminated
21 Nov 2014	Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge” Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.	Device	Class II	3	Completed
29 Sep 2014	CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory…	Device	Class II	1	Terminated
7 Jul 2014	4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit	Device	Class I	6	Terminated
22 Apr 2014	SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.	Device	Class II	1	Terminated
10 Apr 2014	Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration…	Device	Class I	1	Terminated
17 Mar 2014	Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions	Device	Class II	2	Terminated
22 Nov 2013	Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood…	Device	Class II	1	Terminated
22 Nov 2013	4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1¿ needle, and Point-Lok needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via…	Device	Class II	13	Terminated
23 Sep 2013	Portex Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional…	Device	Class II	9	Terminated
10 Sep 2013	Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional…	Device	Class II	2	Terminated
10 Jul 2013	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle…	Device	Class II	5	Terminated
28 Mar 2013	Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being…	Device	Class II	6	Terminated
6 Feb 2013	Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm…	Device	Class I	1	Terminated
27 Jun 2012	Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic…	Device	Class II	1	Terminated
14 Feb 2012	Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.	Device	Class I	1	Terminated
14 May 2010	Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Smiths Medical ASD, Inc.: events for each product type
Type		Events
Device		108

Smiths Medical ASD, Inc.: events in each class
Class		Events
Class II		78
Class I		25
Class III		5

Share of the events of the firm in Class I: 23%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 33

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Smiths Medical ASD, Inc., by the year that the recall started. The largest year is 2017, with 13 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Smiths Medical ASD, Inc.: FDA recalls. https://recallregister.com/firm/smiths-medical-asd-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MN, NH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Smiths Medical ASD, Inc. have?: Class II: 78 events. Class I: 25 events. Class III: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Smiths Medical ASD, Inc.?: FDA event 96628, which the firm started on 10 Apr 2025. The first product in the record is: 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: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH,…
How many FDA recalls of Smiths Medical ASD, Inc. have the status Ongoing?: 33 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.