Data Foundry

Medical device recalls 2019

Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP… — Class II medical device recall Z-1779-2019

Terminated recall by Skytron, Div. The KMW Group, Inc, reported 2019-06-19, distributed nationwide. Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

Recall numberZ-1779-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSkytron, Div. The KMW Group, Inc, Grand Rapids, MI, United States
Recall initiated2019-04-18
Classified2019-06-13
Reported by FDA2019-06-19
Terminated2020-04-17
DistributedNationwide (US)
Quantity5 units
Serial numbers14092619, 14092620, 14102621, 17123520, 18113521

Product

Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

Reason for recall

Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1779-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.