RegWardenFDA facility compliance records
Recall

Class II — Integra LifeSciences Corp.

Recalling firmIntegra LifeSciences Corporation
Registered facilityView this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonIntegra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.
ProductIntegra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
Quantity28,752 units
DistributionAlgeria, Austria, Belgium, Bulgaria, Cyprus, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Lithuania, Luxemborg, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, Argentina, Brazil, Brunei, Chile, China, India, Japan, Korea, Mex…
Initiated2014-07-09
Classified2014-07-17
Terminated2014-10-14
Recall numberZ-2072-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-2072-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68742/

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