Recall archive
61 recalls · page 2 of 3
Reported Jun 16, 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…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the…
FDA (openFDA device enforcement)
Reported May 5, 2021
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 28, 2021
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots…
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 three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171,…
FDA (openFDA device enforcement)
Reported Jan 27, 2021
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Shipping box may contain wrong model.
FDA (openFDA device enforcement)
Reported Jan 6, 2021
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 16, 2020
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Label has the incorrect size for the tracheotomy tube.
FDA (openFDA device enforcement)
Reported Aug 12, 2020
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
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 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…
FDA (openFDA device enforcement)
Reported Jul 8, 2020
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange…
FDA (openFDA device enforcement)
Reported May 6, 2020
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner…
FDA (openFDA device enforcement)
Reported Dec 18, 2019
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Smiths Medical ASD Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Nov 20, 2019
ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
FDA (openFDA device enforcement)
Reported Oct 30, 2019
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2019
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless…
FDA (openFDA device enforcement)
Reported Jun 12, 2019
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Packaged with an incorrect size inner cannula.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2019
Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand · Product details — 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…
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 Dec 5, 2018
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number…
FDA (openFDA device enforcement)
Reported Oct 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Smiths Medical ASD Inc.
Matched: Brand · Product · Product details — "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
4 more products 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 Aug 15, 2018
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jul 18, 2018
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print…
FDA (openFDA device enforcement)
Reported Jun 13, 2018
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
Matched: Brand — Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
FDA (openFDA device enforcement)
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