PlainRecalls

Smiths Medical Asd, Inc.

Compiled from official public sources by the publisher.

293 recalls on record · Latest: May 14, 2025

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Agency notice ledger

Federal filing book Smiths Medical Asd, Inc. HEAVY-BOOK · SINGLE-AGENCY

#37 of 14,151 · 293 notices · 0.281% archive

  • BOOK 293 notices
  • RANK #37 of 14,151
  • SHARE 0.281% archive
  • AGENCY FDA Devices (293)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 14, 2025
  • PHOTO Blue Bell Creameries,…

Nearest notice-volume peer: Blue Bell Creameries, L.P. (1 notice gap)

Smiths Medical Asd, Inc. accounts for about 0.281% of the 104,423-notice archive on 293 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Smiths Medical Asd, Inc.'s standing among 14,151 recalling firms

Smiths Medical Asd, Inc. ranks 37th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Smiths Medical Asd, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

293 37th of 14151 higher than 14,114 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Smiths Medical Asd, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Smiths Medical Asd, Inc. holds about 0.281% of archive notices alongside 293 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Low Oct 10, 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.
FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
FDA Devices Low Sep 26, 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.
FDA Devices Moderate Aug 15, 2018

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
FDA Devices Moderate Jul 18, 2018

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, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 l
FDA Devices Moderate Jun 13, 2018

Bivona¿ Tracheostomy Tube Tracheostomy Tubes
FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 3010 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 delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent
FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 3500 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 delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent
FDA Devices Moderate Mar 28, 2018

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 delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent
FDA Devices Moderate Mar 21, 2018

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)
FDA Devices Moderate Mar 21, 2018

Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
FDA Devices Moderate Feb 21, 2018

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.
FDA Devices Moderate Feb 7, 2018

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
FDA Devices Moderate Jan 10, 2018

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
FDA Devices Moderate Jan 10, 2018

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, enteral solutions and other therapeutic fluids.
FDA Devices Moderate Jan 10, 2018

Medfusion, Syringe Infusion Pump, Software Version 6 (V6), 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, enteral solutions and other therapeutic fluids.
FDA Devices Moderate Nov 8, 2017

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
FDA Devices Moderate Nov 8, 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 CADD-TPN(R) pumps).
FDA Devices Moderate Nov 8, 2017

CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
FDA Devices Moderate Oct 4, 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 more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning
FDA Devices Moderate Sep 6, 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.
FDA Devices Moderate Aug 2, 2017

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
FDA Devices Moderate Jul 12, 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.
FDA Devices Moderate Jun 21, 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.
FDA Devices Moderate Apr 19, 2017

CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
FDA Devices Moderate Mar 22, 2017

Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
FDA Devices Moderate Mar 22, 2017

CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
FDA Devices Low Feb 15, 2017

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.
FDA Devices Moderate Feb 1, 2017

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 controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned

FDA Devices Moderate Dec 28, 2016

Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs 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) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polyp
FDA Devices Moderate Jun 8, 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, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate
FDA Devices Moderate Oct 28, 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.
FDA Devices Moderate Jun 24, 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.
FDA Devices Moderate Jun 17, 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.
FDA Devices Moderate Jun 10, 2015

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
FDA Devices Moderate Mar 25, 2015

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
FDA Devices Low Feb 4, 2015

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, (Glucose and Lactate).
FDA Devices Moderate Jan 7, 2015

Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 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.
FDA Devices Moderate Jan 7, 2015

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.
FDA Devices Moderate Jan 7, 2015

Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 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.
FDA Devices Moderate Nov 12, 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 Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to sen
FDA Devices Critical Sep 3, 2014

H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Devices Critical Sep 3, 2014

H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
FDA Devices Critical Sep 3, 2014

H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Devices Critical Sep 3, 2014

H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Devices Critical Sep 3, 2014

4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Devices Critical Sep 3, 2014

H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Devices Critical Jun 18, 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 of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.

Smiths Medical Asd, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Cardinal Health 200, LLC 285 Philips Medical Systems (Cleveland) Inc 315 Cook Inc. 264 The Anspach Effort, Inc. 261

Frequently Asked Questions

How many federal recall notices name Smiths Medical Asd, Inc.? ▼
PlainRecalls indexes 293 distinct federal recall events naming Smiths Medical Asd, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Smiths Medical Asd, Inc. sit among other recalling firms? ▼
Smiths Medical Asd, Inc. ranks #37 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Smiths Medical Asd, Inc.'s notices? ▼
FDA Devices accounts for 293 of this firm's 293 indexed notices.
What product category dominates Smiths Medical Asd, Inc.'s filing book? ▼
Filings for Smiths Medical Asd, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Smiths Medical Asd, Inc.: 293 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Smiths Medical Asd, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026