Engineered Medical Systems,Inc: Medical Device Recall in 2013 - (Recall #: Z-1058-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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. .

Product Classification:

Class I

Date Initiated: September 12, 2011

Date Posted: April 17, 2013

Recall Number: Z-1058-2013

Event ID: 64751

Reason for Recall:

The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Status: Terminated

Product Quantity: 1500pcs, 75cs {20pcs per cases)

Code Information:

REF 8-205508-00 Lot Number: 820550800110419.

Distribution Pattern:

Distributed in the states of PA, IN, NY, CO, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated