Recall archive
92 recalls · page 2 of 4
Reported Jan 18, 2023
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected…
FDA (openFDA device enforcement)
Reported Aug 3, 2022
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or…
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Integra Universal Flexible Arm part number REF 1362275
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA (openFDA device enforcement)
Reported Mar 30, 2022
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
FDA (openFDA device enforcement)
Reported Apr 14, 2021
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Incorrect labeling, Catheter did not have the required holes and markings
FDA (openFDA device enforcement)
Reported Dec 30, 2020
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2020
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
FDA (openFDA device enforcement)
Reported Sep 23, 2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2020
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Integra LifeSciences Corp.
Matched: Brand — Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
FDA (openFDA device enforcement)
Reported Dec 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current…
41 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — There is a potential for a progressive decline in observed ICP readings of the monitor during use.
FDA (openFDA device enforcement)
Reported Sep 11, 2019
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the…
FDA (openFDA device enforcement)
Reported Aug 14, 2019
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
FDA (openFDA device enforcement)
Reported May 29, 2019
MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Integra LifeSciences Corp.
Matched: Brand — The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2019
Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Reason for recall — The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant…
25 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 8, 2018
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 16, 2018
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Incorrect gel part number listed in a master manufacturing record
FDA (openFDA device enforcement)
Reported May 2, 2018
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1)…
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Panta Nail, Rx only, Sterile,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand — Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide…
FDA (openFDA device enforcement)
Reported Mar 15, 2017
The UNI-CP System; Model Number: 330230SND.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Integra LifeSciences Corp.
Matched: Brand — The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
FDA (openFDA device enforcement)
Reported Feb 22, 2017
Integra Cadence Total Ankle System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — Posterior tibial fractures have been reported.
FDA (openFDA device enforcement)
Reported Oct 12, 2016
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
Matched: Brand · Product · Product details — During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
5 more products in this recall
FDA (openFDA device enforcement)
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