The Recall Desk

Manufacturer

Battelle Memorial Institute

1 recall in our database name Battelle Memorial Institute as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2020-11-04

Of the 1 recalls from Battelle Memorial Institute 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-0309-2021·2020-11-04

    Battelle Recalls Critical Care Decontamination System N95 Respirators

    Battelle Memorial Institute is recalling 898 N95 respirators decontaminated by its Critical Care Decontamination System. The recall is due to a failure to maintain required condensation levels during the decontamination cycle.

    Product
    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are
    Category
    Medical Device
    Distribution
    Distributed nationwide