CLASS II ONGOING Device recall · Reported 23 Oct 2019 · FDA Enforcement Report

Cerelink ICP Monitor recalled by Integra LifeSciences

Integra LifeSciences is recalling Cerelink ICP Monitor, distributed in 11 states. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll systems

Quantity recalled189

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0124-2020
FDA event ID: 83831
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 12 Sep 2019
FDA classified: 12 Oct 2019
Reported: 23 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

12 Sep 2019	Recall initiated by company
12 Oct 2019	Classified by FDA	+30 days
23 Oct 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for a progressive decline in observed ICP readings of the monitor during use.

Product as listed by the FDA

Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.

Where it was distributed

The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.

California Colorado Connecticut Florida Indiana New York Oklahoma Pennsylvania Texas Wisconsin West Virginia

Questions about this recall

Why was it recalled?

There is a potential for a progressive decline in observed ICP readings of the monitor during use.

Which lots are affected?

All systems

Where was it sold?

The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integra LifeSciences

All 246

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	Aurora Surgiscope System, Sterile recalled by Integra LifeSciences	Integra LifeSciences	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Right Angle Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide