Recall archive
10 recalls · page 1 of 1
Reported Sep 21, 2016
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Product · Product details · Reason for recall — Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result…
FDA (openFDA device enforcement)
Reported May 27, 2015
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2015
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Reason for recall — Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during…
FDA (openFDA device enforcement)
Reported Jun 11, 2014
Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Product · Product details — New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S)…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. d.b.a. Integra Pain Management
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory…
FDA (openFDA device enforcement)
Reported Oct 30, 2013
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details · Reason for recall — Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2013
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Product · Product details · Reason for recall — As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the…
FDA (openFDA device enforcement)
Reported May 22, 2013
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand — Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Product · Product details · Reason for recall — An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2012
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corporation
Matched: Brand · Product · Product details · Reason for recall — T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the…
1 more product in this recall
FDA (openFDA device enforcement)
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