Z-1563-2016Class II

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL

Name: Z-1563-2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL
Creator: 3M Company - Health Care Business
Published: 2016-01-22
License: https://open.fda.gov/license/

3M Company / initiated 2016-01-22 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL on 2016-01-22. FDA classified it as Class II and gives the reason as "3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1563-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-22
Posted: 2016-04-24
Terminated: 2016-08-25
Recalling firm: 3M Company
Product: 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Product code: FLF Sterilizer, Ethylene-Oxide Gas
Reason for recall: 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.
Quantity in commerce: 74 valves
Distribution: AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.
Product codes and lots: Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360 Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1563-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1563-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-24

Product code FLF

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)