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Integra LifeSciences Corp.

Integra LifeSciences Corp. Recalls

All product recalls associated with Integra LifeSciences Corp..

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Recall Summary

Total Recalls

710

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 661–680 of 710 recalls

Integra LifeSciences Corp.: Selector Ultrasonic Integra Ultrasonic Aspirator System, ...

Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.

FDASep 13, 2005Nationwide• Integra LifeSciences Corp.

Integra Neuro Sciences: NeuroSensor Cerebral Blood Flow and Intracranial Pressure...

Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring.

FDASep 8, 2005Nationwide• Integra Neuro Sciences

Medtronic Emergency Response Systems, Inc.: standard (hard) paddles used with the LIFEPAK 12 defibril...

Potential for voltage pins in connector of therapy cable to break.

1...32 333435 36

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FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables use...

Potential for voltage pins in connector of therapy cable to break.

FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Tosoh Bioscience, Inc.: Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog ...

The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.

FDAAug 18, 2005PR• Tosoh Bioscience, Inc.

Medtronic Emergency Response Systems, Inc.: Hard shell carry case for the LIFEPAK 500 AED.

Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).

FDAJul 12, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

ATV Wheels (HiPer Technology) – Potential Failure (2005)

The recalled 9-inch ATV aftermarket rear wheels have a model number of 0990 YHR. The rear wheels were manufactured from February 15, 2005 through May 2005. The recalled wheel can be used as the rear wheel on ATVs having the following bolt patterns: four bolts on a 110mm circle or four bolts on a 115mm circle. The center section of the wheel is made of aluminum and has eight bolt holes.

CPSCJul 1, 2005Nationwide• HiPer Technology Inc., of Lawrence, Kan.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defbrillator/monitor

The defibrillator may not operate if the device is turned on during an AC Loss Alert.

FDAJun 17, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Esa Biosciences, Inc.: LeadCare Blood Lead Testing System Kits Catalog Number: 7...

Lead test results may be reported lower than the actual value

FDAMay 19, 2005Nationwide• Esa Biosciences, Inc.

Edwards Lifesciences Llc One Edwards Way: Edwards LifeStent NT Self-Expanding Stent and Delivery Sy...

Potential for deployment difficulties.

FDAApr 28, 2005Nationwide• Edwards Lifesciences Llc One Edwards Way

Medtronic Emergency Response Systems, Inc.: LIFEPAK 500 AED.

Potential to not detect patients at the low end of the patient impedance range.

FDAFeb 3, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Integra Neuro Sciences: LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

FDAJan 21, 2005CA, CO, DE +21 more• Integra Neuro Sciences

Integra Neuro Sciences: LICOX temperature probe, Model C8.B

FDAJan 21, 2005CA, CO, DE +21 more• Integra Neuro Sciences

Medtronic Emergency Response Systems, Inc.: LIFEPAK 12 defibrillator/ monitors biphasic

The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

FDAJan 15, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Ocular Sciences, Inc.: Sunsoft Multiples Toric, methafilcon A, clear contact lens.

Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.

FDADec 9, 2004AZ, AR, CA +12 more• Ocular Sciences, Inc.

Edwards Lifesciences Research Medical Inc: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

FDANov 19, 2004AL, CA, CO +21 more• Edwards Lifesciences Research Medical Inc

Cardiac Science, Inc.: Powerheart AED G3 Automated External Defibrillator Model ...

AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.

FDANov 12, 2004Nationwide• Cardiac Science, Inc.

Manitou Bicycle Suspension Forks – Structural Risk (2004)

The recall involves 2005 Manitou Nixon, Stance, and Sherman bicycle suspension forks installed on various high-end mountain bicycles. The Manitou bicycle suspension forks have the model names printed on the sides of the lower leg portions of the fork. Specific models are listed in the table below. 2005 Manitou Nixon Comp, Platinum, Super and Super Plus 145 Suspension Fork Elite 115-145 Suspension Fork Sherman Jumper 110 Suspension Fork Stance Static 80 & 100 Suspension Fork Blunt 100 & 130 Suspension Fork Flow 100-130 Suspension Fork

CPSCNov 8, 2004Nationwide• Answer Products, Inc., of Valencia, CA

Tosoh Bioscience, Inc.: Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH A...

On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.

FDASep 23, 2004CA, CO, FL +7 more• Tosoh Bioscience, Inc.

Independence Technology LLC: iBOT 3000 Mobility System, Independence iBOT 3000 Mobilit...

Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.

FDAAug 30, 2004IN, VA• Independence Technology LLC