Smiths Medical ASD Inc. recalls
108 recalls in our records from 2012 to 2025: 108 FDA medical devices.
Recalls with full detail pages
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Smiths Medical ASD, Inc. medical device recall: CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply…
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to…
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis HPCA Ambulatory Infusion Pump
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of…
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Smiths Medical ASD, Inc. medical device recall: smiths medical ProPort Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
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Smiths Medical ASD, Inc. medical device recall: Portex Endotracheal Tube
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or…
Earlier and other recalls
These link to the official agency notice.
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Smiths Medical ASD, Inc. medical device recall: CAPNOCHECK BCI Airway Adapter Official notice ↗
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,…
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Smiths Medical ASD, Inc. medical device recall: smiths medical portex Venn Reusable Tracheal Tube Introducer Official notice ↗
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…
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Smiths Medical ASD, Inc. medical device recall: smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter Official notice ↗
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 one or more of the…
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Smiths Medical ASD Inc. medical device recall: CADD-Solis Li-ion Rechargeable Battery Packs Official notice ↗
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the…
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Smiths Medical ASD, Inc. medical device recall: medex TranStar Single OR Set 1/EA Official notice ↗
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…
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Smiths Medical ASD Inc. medical device recall: CADD Medication Cassette Reservoir Official notice ↗
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could…
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Smiths Medical ASD Inc. medical device recall: smiths medical portex Official notice ↗
Uncertainty in the seal integrity of the sterile packaging.
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Smiths Medical ASD Inc. medical device recall: paraPAC plus 310 ventilator kit with internal PEEP and CPAP Official notice ↗
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators…
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Smiths Medical ASD Inc. medical device recall: Pneupac paraPAC plus 300 ventilator kit Official notice ↗
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
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Smiths Medical ASD Inc. medical device recall: smiths medical portex BLUselect Official notice ↗
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc…
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Smiths Medical ASD Inc. medical device recall: PORTEX Bivona Tracheostomy Silicone Tube Official notice ↗
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a…
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Smiths Medical ASD Inc. medical device recall: CADD-Solis Ambulatory Infusion Pumps Official notice ↗
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3.…
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Smiths Medical ASD Inc. medical device recall: Smiths Medical Medfusion Model 3500 Syringe pumps Official notice ↗
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may…
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Smiths Medical ASD Inc. medical device recall: smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and… Official notice ↗
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the…
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Smiths Medical ASD Inc. medical device recall: smiths medical Medfusion Model 4000 syringe pump Official notice ↗
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority…
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Smiths Medical ASD Inc. medical device recall: smiths medical Medfusion Model 3500 Syringe pump Official notice ↗
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion…
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Smiths Medical Asd Inc medical device recall: Medex LOGICAL CATH LAB KIT Official notice ↗
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal…
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Smiths Medical ASD Inc. medical device recall: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube Official notice ↗
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date…
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Smiths Medical ASD Inc. medical device recall: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin… Official notice ↗
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically,…
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Pump Official notice ↗
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm.…
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Smiths Medical ASD Inc. medical device recall: PORTEX 0.5u HYDROPHOBIC DISC FILTER Official notice ↗
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
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Smiths Medical ASD Inc. medical device recall: DuraLife Autoclavable Double Swivel Elbow Official notice ↗
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the…
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Smiths Medical ASD Inc. medical device recall: CADD Administration Set Official notice ↗
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable…
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Smiths Medical ASD Inc. medical device recall: Medfusion Model 4000 Syringe Infusion Pump Official notice ↗
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and…
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Pump Model: Model 4000-0100-50 Official notice ↗
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base…
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Smiths Medical ASD Inc. medical device recall: Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion… Official notice ↗
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur…
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Smiths Medical ASD Inc. medical device recall: Pneupac paraPac plus 300 ventilator kit Official notice ↗
Two devices were labeled with the same serial number
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Smiths Medical ASD Inc. medical device recall: Bivona Aire-Cuf Endotracheal Tube Official notice ↗
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
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Smiths Medical ASD Inc. medical device recall: smiths medical portex Loss of Resistance Device Official notice ↗
The labeling was missing information on sterilization and prohibition of reuse.
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Smiths Medical ASD Inc. medical device recall: CADD Administration Sets Official notice ↗
Product may have been manufactured with an air filter assembled in an incorrect orientation.
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Smiths Medical ASD Inc. medical device recall: medfusion Stopcock Official notice ↗
Product has a lack of sterility assurance
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Smiths Medical ASD Inc. medical device recall: CADD-Solis VIP ambulatory infusion pump Official notice ↗
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air…
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Smiths Medical ASD Inc. medical device recall: medex LogiCal 5mL Closed Blood Sampling System Official notice ↗
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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Smiths Medical ASD Inc. medical device recall: NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 Official notice ↗
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
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Smiths Medical ASD Inc. medical device recall: smiths medical portex Tracheal Intubation Stylet Official notice ↗
The incorrect device is contained in the package.
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Smiths Medical ASD Inc. medical device recall: PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit Official notice ↗
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
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Smiths Medical ASD Inc. medical device recall: JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL… Official notice ↗
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were…
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Smiths Medical ASD Inc. medical device recall: Palm Cups - Product Usage: intended to be used to percuss the chest… Official notice ↗
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
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Smiths Medical ASD Inc. medical device recall: LogiCal Monitoring Set Official notice ↗
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or…
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Smiths Medical ASD Inc. medical device recall: Tube Tracheostomy and Tube Cuff Official notice ↗
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and…
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Smiths Medical ASD Inc. medical device recall: Portex Acapella DH Vibratory PEP Device - Product Usage: a single… Official notice ↗
Shipping box may contain wrong model.
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Smiths Medical ASD Inc. medical device recall: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube Official notice ↗
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
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Smiths Medical ASD Inc. medical device recall: Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is… Official notice ↗
Label has the incorrect size for the tracheotomy tube.
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Pump Model 4000 Official notice ↗
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
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Smiths Medical ASD Inc. medical device recall: PORT-A-CATH¿ II POWER P.A.C. Low Profile" system Official notice ↗
Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr…
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Smiths Medical ASD Inc. medical device recall: Pediatric Adjustable Flange Tracheostomy Tube Cuffless Official notice ↗
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
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Smiths Medical ASD Inc. medical device recall: Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 -… Official notice ↗
Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as…
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Smiths Medical ASD, Inc. medical device recall: Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium… Official notice ↗
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Pump Official notice ↗
There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm…
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Smiths Medical ASD Inc. medical device recall: ProtectIV¿ Plus Safety IV Catheter Official notice ↗
Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
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Smiths Medical ASD Inc. medical device recall: GRIPPER Needles sold individually. Labeled as the following item… Official notice ↗
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
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Smiths Medical ASD Inc. medical device recall: Medfusion¿ Model 4000 Syringe Infusion Pump Official notice ↗
Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity…
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Smiths Medical ASD Inc. medical device recall: Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety… Official notice ↗
Incorrect needle length and gage.
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Smiths Medical ASD Inc. medical device recall: Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula… Official notice ↗
Packaged with an incorrect size inner cannula.
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Smiths Medical ASD Inc. medical device recall: Jelco(R) ViaValve(TM) safety intravenous Official notice ↗
Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was…
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Smiths Medical ASD Inc. medical device recall: Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent… Official notice ↗
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
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Smiths Medical ASD Inc. medical device recall: Medex High Pressure Stopcock used to control the direction of IV… Official notice ↗
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L…
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Smiths Medical ASD Inc. medical device recall: smiths medical portex First Breath Adult Nasal Cannula Official notice ↗
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
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Smiths Medical ASD Inc. medical device recall: Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin… Official notice ↗
The product was mislabeled with the incorrect label.
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Infusion Pump Official notice ↗
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or…
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Smiths Medical ASD Inc. medical device recall: BCI Advisor Vital Signs Monitor Official notice ↗
Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
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Smiths Medical ASD Inc. medical device recall: Bivona¿ Tracheostomy Tube Tracheostomy Tubes Official notice ↗
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
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Smiths Medical ASD Inc. medical device recall: Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion… Official notice ↗
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize…
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Smiths Medical ASD Inc. medical device recall: PORT-A-CATH II PS/Titan Official notice ↗
Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the…
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Smiths Medical ASD, Inc. medical device recall: Custom Made Tracheostomy Device The CADD Administration Sets with… Official notice ↗
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
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Smiths Medical ASD Inc. medical device recall: Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient… Official notice ↗
In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
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Smiths Medical ASD Inc. medical device recall: CADD-Legacy 1 Official notice ↗
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 serial number that does…
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Smiths Medical ASD Inc. medical device recall: Medfusion Official notice ↗
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit…
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Smiths Medical ASD Inc. medical device recall: CADD(TM) Medication Cassette Reservoir with clamp and female Luer.… Official notice ↗
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
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Smiths Medical ASD Inc. medical device recall: UniPerc(R) Adjustable Flange Tracheostomy Tube kit Official notice ↗
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971,…
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Smiths Medical ASD Inc. medical device recall: CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non… Official notice ↗
The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on…
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Smiths Medical ASD Inc. medical device recall: Smiths Medical CADD Blue-Striped IV Administration Set Official notice ↗
The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.
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Smiths Medical ASD Inc. medical device recall: Jelco Official notice ↗
Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The…
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Smiths Medical ASD Inc. medical device recall: CADD¿ High Volume Administration Set with FlowStop Official notice ↗
One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.
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Smiths Medical ASD Inc. medical device recall: CADD¿ Administration Set Official notice ↗
Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24),…
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Smiths Medical ASD Inc. medical device recall: Bivona¿ TTS Official notice ↗
Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly…
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Smiths Medical ASD, Inc. medical device recall: CADD Solis VIP Ambulatory Infusion Pump Official notice ↗
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 presses the pump…
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Smiths Medical ASD, Inc. medical device recall: HOTLINE Blood and Fluid Warmer Official notice ↗
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.
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Smiths Medical ASD, Inc. medical device recall: NORMFlow H-110 Irrigation Fluid Warmer Official notice ↗
Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels.…
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Smiths Medical ASD Inc. medical device recall: Acuvance¿2 Safety Catheter Official notice ↗
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port…
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Smiths Medical ASD, Inc. medical device recall: CADD Administration Sets with Flow Stop Official notice ↗
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
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Smiths Medical ASD, Inc. medical device recall: PORT-A-CATH Plastic Hub Needles Official notice ↗
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 description and product…
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Smiths Medical ASD, Inc. medical device recall: CADD¿- Solis Ambulatory Infusion Pump Official notice ↗
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 the Cassette/ Keypad…
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Smiths Medical Asd Inc medical device recall: Low Volume Extension Set Official notice ↗
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 production of 1 lot of…
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Smiths Medical ASD, Inc. medical device recall: Smiths Medical Official notice ↗
The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of…
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Smiths Medical ASD, Inc. medical device recall: CADD" Medication Cassette Reservoir Official notice ↗
Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs ( Cassette ). Some Cassettes may leak at the sealing area of…
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Smiths Medical ASD, Inc. medical device recall: Portex Anaerobic Pulsator Arterial Blood Sampling Kit Official notice ↗
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 expiration date by…
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Smiths Medical ASD, Inc. medical device recall: Hypodermic Needle Pro¿ Edge" Safety Device 20G x1 Official notice ↗
Needle is not captured in the needle safety sheath in specific lots.
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Smiths Medical ASD, Inc. medical device recall: CADD-Solis Medication Safety Software Official notice ↗
Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis…
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Smiths Medical ASD, Inc. medical device recall: 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy Official notice ↗
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when…
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Smiths Medical ASD, Inc. medical device recall: Portex Low Dead Space Connector with Sideport Official notice ↗
One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
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Smiths Medical ASD, Inc. medical device recall: SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket Official notice ↗
The hose could separate from the blanket.
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Smiths Medical ASD, Inc. medical device recall: Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage:… Official notice ↗
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
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Smiths Medical ASD, Inc. medical device recall: 4040-2: Umbilical 3 mL Line Draw Official notice ↗
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
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Smiths Medical ASD, Inc. medical device recall: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin… Official notice ↗
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
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Smiths Medical ASD, Inc. medical device recall: Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe… Official notice ↗
Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC…
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Smiths Medical ASD, Inc. medical device recall: Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre Official notice ↗
Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These…
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Smiths Medical ASD, Inc. medical device recall: Smith Medical Official notice ↗
Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical…
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Smiths Medical ASD, Inc. medical device recall: Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters Official notice ↗
Unable to pass catheter through outer sheath during embryo transfer
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Smiths Medical ASD, Inc. medical device recall: Smiths Medical Official notice ↗
In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.