The Recall Desk

Manufacturer

Engineered Medical Systems,Inc

1 recall in our database name Engineered Medical Systems,Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2013-04-17

Of the 1 recalls from Engineered Medical Systems,Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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

  • SevereFDA (Devices)·Z-1058-2013·2013-04-17

    Respironics Infant Masks Recalled Due to Incorrect Size Labeling

    Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.

    Product
    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
    Category
    Medical Device
    Distribution
    5 states