FDA Medical Device Recalls (openFDA)
Skytron, Div. The KMW Group, Inc: 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
- Recall number
- Z-1779-2019
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- 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
- Status
- Terminated
- Initiated
- 2019-04-18
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
- 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 www.lperez@skytron.us, or Bob Vreeland, at 616-656-1189 or www.bvreeland@skytron.us with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).
- Quantity
- 5 units
- Distribution
- US Nationwide Distribution - AK, IA, MS
- Lot, serial or model codes
- Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521
- 510(k) numbers
- ["K132439"]
- PMA numbers
- not on file
- Product code
- FLE
- Firm FEI
- 1825014
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28