Lower riskMedical device recall · FDA · Published December 1, 2017
Mindray Gas Module 3 Spirometer Recall: Updated Safety Requirements
Mindray recalls Gas Module 3 spirometers (part 115-030108-00) purchased between Feb 2008 and Oct 2015 due to regulatory changes requiring new safety approvals. This update ensures continued safe use in medical settings.
“Mindray Gas Module 3 Spirometer Recall: Updated Safety Requirements.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72414-mindray-gas-module-3-spirometer-recall-updated-safety-requirements. Based on FDA recall #Z-1242-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2018%22&limit=1).
The FDA announced on December 1, 2017, that Mindray DS USA, Inc. dba Mindray North America is recalling Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring a new 510(k) premarket notification.
How to tell if you have it
Brand: Mindray
Product: Gas Module 3 monitoring spirometer
Part Number: 115-030108-00
Units affected: 1719
The hazard
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Context
GovInfoNow's records show Mindray DS USA, Inc. dba Mindray North America has 13 other recalls on record since July 14, 2017. Other recent recalls of similar products include Baxter Blue Ventilator Adapter Module Recall (February 18, 2026), Medline PICC Tray DYNJ41648A Recall (February 25, 2026), and 3B Medical React Health PHOENIX 5L Oxygen Concentrator Recall (February 4, 2026).
How to tell if you have this one
Check for part number 115-030108-00 on the Gas Module 3 spirometer. The device was purchased between February 14, 2008, and October 2015.
Brand
Mindray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the part number on the Gas Module 3 spirometer to confirm if it falls within the recall range.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1242-2018 (December 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1242-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.