Recall archive
39 recalls · page 1 of 2
Reported May 14, 2025
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand — Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 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
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD, Inc.
Matched: Brand — Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience…
FDA (openFDA device enforcement)
Reported Dec 4, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or…
FDA (openFDA device enforcement)
Reported Oct 30, 2024
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero…
23 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 22, 2020
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details — The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2018
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD Inc.
Matched: Brand · Product details — The product was mislabeled with the incorrect label.
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
FDA (openFDA device enforcement)
Reported Jan 10, 2018
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2017
CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details · Reason for recall — Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2017
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details — The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key…
FDA (openFDA device enforcement)
Reported 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…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD, Inc.
Matched: Brand — HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
FDA (openFDA device enforcement)
Reported Feb 1, 2017
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead…
FDA (openFDA device enforcement)
Reported Jun 8, 2016
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number…
FDA (openFDA device enforcement)
Reported Jun 24, 2015
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD¿-Solis pumps. Binding of…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical Asd Inc.
Matched: Brand · Product details · Reason for recall — Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the…
FDA (openFDA device enforcement)
Reported Jun 10, 2015
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Product · Product details — The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being…
FDA (openFDA device enforcement)
Reported Mar 25, 2015
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand · Reason for recall — Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs ( Cassette ). Some Cassettes may leak at…
FDA (openFDA device enforcement)
Reported Feb 4, 2015
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD, Inc.
Matched: Brand — The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual…
FDA (openFDA device enforcement)
Reported Jan 7, 2015
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
Matched: Brand — Needle is not captured in the needle safety sheath in specific lots.
2 more products in this recall
FDA (openFDA device enforcement)
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