Recall archive
61 recalls · page 1 of 3
Reported Nov 6, 2024
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — 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)…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670,…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
smiths medical Medfusion Model 3500 Syringe pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details · Reason for recall — Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct…
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — 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)…
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Reason for recall — Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
FDA (openFDA device enforcement)
Reported May 24, 2023
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2)…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 30, 2022
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on…
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period.…
FDA (openFDA device enforcement)
Reported Nov 3, 2021
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD Inc.
Matched: Brand — Two devices were labeled with the same serial number
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 27, 2021
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 20, 2021
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — The incorrect device is contained in the package.
FDA (openFDA device enforcement)
Reported Jul 7, 2021
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — 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.
FDA (openFDA device enforcement)
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