VERIFY SixCess LCC003Recalls & reported problems

Steris Corporation · The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can be used to release non implant loads. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Aug 10, 2022Terminated
Product contains incorrect chemical indicators in packaging.
Z-1736-2022 · Root cause: Process control · FDA record ↗

Device details

UDI-DI	`10724995088955`
Brand	VERIFY SixCess
Model	LCC003
Company	Steris Corporation
Product code	JOJ · Indicator, physical/chemical sterilization process
Class	Class 2
FDA submission	K070895, K073683, K162758
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Nov 3, 2022

Device type (GMDN): Biological sterilization indicator

A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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