Integra Lifesciences Corp.
Plainsboro, NJ
This page shows every FDA and USDA recall linked to Integra Lifesciences Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
210
Total Recalls
2002
First Recall
2019
Most Recent
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV,...
Mar 2, 2012
· Device
Terminated
Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspir...
Feb 8, 2012
· Device
Terminated
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
Feb 3, 2012
· Device
Terminated
Luxtec UltraLite Headlight System sweatband with short linkage
Model: AXI385BIFSL
Product Usage: The fiber...
Jan 11, 2012
· Device
Terminated
Luxtec UltraLite Pro Headlight with 9ft bifurcated cable
Model: AX2000BIF
Product Usage: The fiber optic hea...
Jan 11, 2012
· Device
Terminated
UltraLite Headlight module-grey
Model: 001328
Product Usage: The fiber optic headlight system Is designed...
Jan 11, 2012
· Device
Terminated
Mark II Headlight module-black with short linkage
Model: 001380LXSL
Product Usage: The fiber optic headlig...
Jan 11, 2012
· Device
Terminated
Mark II Headlight module-black
Model: 001380LX
Product Usage: The fiber optic headlight system Is designed...
Jan 11, 2012
· Device
Terminated
Luxtec UltraLite Headlight System Headband
Model: AXI375BIF
Product Usage: The fiber optic headlight system...
Jan 11, 2012
· Device
Terminated
Luxtec UltraLite Headlight System with 9ft premium bifurcated cable
Model: AX2100BIF
Product Usage: The fib...
Jan 11, 2012
· Device
Terminated
Luxtec UltraLite Headlight System sweatband
Model: AXI385BIF
Product Usage: The fiber optic headlight syste...
Jan 11, 2012
· Device
Terminated
Luxtec UltraLite Headlight System with short linkage
Model: AX 1375BIFSL
Product Usage: The fiber optic hea...
Jan 11, 2012
· Device
Terminated
Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXEU
Dec 2, 2011
· Device
Terminated
Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXAU
Product Usage: The Integra Luxtec MLX Li...
Dec 2, 2011
· Device
Terminated
Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLX
Product Usage: The Integra Luxtec MLX Ligh...
Dec 2, 2011
· Device
Terminated
Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO,...
Jun 22, 2011
· Device
Terminated
Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO,...
Jun 22, 2011
· Device
Terminated
Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Mo...
May 20, 2011
· Device
Terminated
Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement Sys...
May 19, 2011
· Device
Terminated
Manta Ray" Anterior Cervical Plate (ACP) System,
Intended use: The Manta Ray ACP System is an anterior cervi...
May 13, 2011
· Device
Terminated
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT...
May 13, 2011
· Device
Terminated
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South,...
May 10, 2011
· Device
Terminated
Luxtec MLX 300 Watt Xenon Light Source,
Model OOMLX; Surgical/Medical Light Source
This light source is desi...
Apr 25, 2011
· Device
Terminated
LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, So...
Mar 3, 2011
· Device
Terminated
Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments...
Mar 2, 2011
· Device
Terminated
Integra Radionics HRAIM Intubation Head Ring Assembly
Ref: HRAIM Head Rings serve as the general stereotactic...
Feb 23, 2011
· Device
Terminated
Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroScie...
Feb 14, 2011
· Device
Terminated
Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
The...
Jan 25, 2011
· Device
Terminated
DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corporati...
Nov 24, 2010
· Device
Terminated
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corpora...
Nov 24, 2010
· Device
Terminated
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corpora...
Nov 24, 2010
· Device
Terminated
DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corpora...
Nov 24, 2010
· Device
Terminated
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches.
Non Pyrogenic; Rx only;Integra LifeSciences Corpora...
Nov 24, 2010
· Device
Terminated
Licox Brain PMO Probe Kit;
Ref IP2.P;
Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP...
Oct 28, 2010
· Device
Terminated
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System
CUSANXT1:Latex Free, Rx only:
Integra LifeScience...
Sep 30, 2010
· Device
Terminated
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System
CUSANXT2: Latex Free, Rx only.
Integra LifeScienc...
Sep 30, 2010
· Device
Terminated
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter;
Sterile, Rx only....
Sep 28, 2010
· Device
Terminated
Integra NeuroSciences Implants, NeuroBalloon Catheter,
Sterile/EO, Rx only, single use, latex free: Catalog Nu...
Sep 22, 2010
· Device
Terminated
Integra, Licox Ref 1P2.P;
Brain PMO-Probe Kit
Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes...
Apr 20, 2010
· Device
Terminated
Suturable DuraGen Dural Regeneration Matrix;
Non-Pyrogenic;
Sterility guaranteed unless package is damaged or...
Mar 11, 2010
· Device
Terminated
Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store...
Apr 7, 2009
· Device
Terminated
Integra Dermal Regeneration Template-TS
Catalog number 32021
Catalog number 82021
Mar 6, 2009
· Device
Terminated
Integra Mosaik Putty, 15cc, Catalog # PTY10256
Integra Lifesciences, Plainsboro, NJ
Mar 6, 2009
· Device
Terminated
Integra Ruggles Surgical Instrument ACF Distraction Screws
Sterile, Rx only
Catalog number R6357A (12 mm), Cat...
Jan 23, 2009
· Device
Terminated
Gravity Compensating Accessory;
High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory.
Man...
Dec 12, 2008
· Device
Terminated
Uni-CP Compression Forceps (spreader);
Non-sterile, R only, Catalog number: 339001ND
Newdeal, Lyon, France;
In...
Dec 1, 2008
· Device
Terminated
Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile;
Integra LifeSciences Corporation, 3...
Sep 20, 2008
· Device
Terminated
PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newd...
Sep 16, 2008
· Device
Terminated
QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or f...
Aug 15, 2008
· Device
Terminated
QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or f...
Aug 15, 2008
· Device
Terminated