The Recall Desk

Manufacturer

Integra Burlington MA, Inc.

1 recall in our database name Integra Burlington MA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2013-04-10

Of the 1 recalls from Integra Burlington MA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-1030-2013·2013-04-10

    Integra Ojemann Cortical Stimulator Recalled for Potential Electrical Injury Risk

    Integra Burlington MA, Inc. is recalling 371 Ojemann Cortical Stimulators because a non-intended voltage could be transmitted to patients during surgery.

    Product
    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide