Recall archive
27 recalls · page 1 of 2
Reported Nov 6, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
FDA (openFDA device enforcement)
Reported May 1, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach,…
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is…
FDA (openFDA device enforcement)
Reported Aug 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LP
Matched: Brand — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based…
24 more products in this recall
FDA (openFDA device enforcement)
Reported May 3, 2023
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2023
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LP
Matched: Brand — There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in…
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand · Product · Product details · Reason for recall — Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Brand · Reason for recall — Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Brand — Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active…
FDA (openFDA device enforcement)
Reported Aug 5, 2015
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Brand — Potential missing segments on the display that can result in misinterpretation of data.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2015
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Brand — Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2015
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Matched: Brand · Reason for recall — Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately…
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Product · Product details · Reason for recall — Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing…
FDA (openFDA device enforcement)
Reported Nov 5, 2014
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Product · Product details — A software issue may lead to ventilator inoperative situations.
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Reason for recall — Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2014
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Reason for recall — Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical…
FDA (openFDA device enforcement)
Reported Jun 25, 2014
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand — In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support…
FDA (openFDA device enforcement)
Reported May 21, 2014
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand — Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue…
FDA (openFDA device enforcement)
Reported Jan 29, 2014
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Reason for recall — Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2013
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand · Product · Product details — Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the…
FDA (openFDA device enforcement)
Reported Oct 3, 2012
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LP
Matched: Brand · Product · Product details — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
7 more products in this recall
FDA (openFDA device enforcement)
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