Z-1779-2019Class II

Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam

Name: Z-1779-2019 Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam
Creator: Skytron, Div. The KMW Group, Inc
Published: 2019-04-18
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2019-04-18 / Terminated / root cause: design

FDA source

Skytron, Div. The KMW Group, Inc began a recall of Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care... on 2019-04-18. FDA classified it as Class II and gives the reason as "Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1779-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Posted: 2019-06-13
Terminated: 2020-04-17
Recalling firm: Skytron, LLC
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
Product code: FLE Sterilizer, Steam
Reason for recall: Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
Root cause tag: design
FDA root cause: Device Design
Action: Skytron issued Medical Device Correction letter on 4/18/19 via certified mail stating: reason for recall, action to be taken and will replace the air heater assembly on the affected devices. Contact Larry Perez, Vice President of Technical Services, at 616-656-2900 or [email protected], or Bob Vreeland, at 616-656-1189 or [email protected] with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).
Quantity in commerce: 5 units
Distribution: US Nationwide Distribution - AK, IA, MS
Product codes and lots: Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1779-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1779-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13

Product code FLE

K132439Class IISakura Steam Sterilizer Assr; -Ao12, -A012w, -Ao12p,-Ao12pw / Skytron Integrity 270;Steam Sterilizer,vp Steam SterilizerSakura Seiki Co., Ltd. / cleared 2014-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)