Use cautionMedical device recall · FDA · Published March 1, 2023
Atrium Medical Express Mini 500 Dry Seal Chest Drain Recall: Inadequate Safety
Atrium Medical recalls Express Mini 500 Dry Seal Chest Drains (Part 16400) due to insufficient safety instructions for home use, risking injury if misused outside healthcare settings.
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Take action
Contact the company
📍Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332
✎ GovInfoNow plain-language explainer
Atrium Medical is recalling Express Mini 500 Dry Seal Chest Drains (Part Number 16400) because the safety instructions don't properly warn about using them outside medical settings or prevent improper drainage. This could lead to injury if someone tries to use the device incorrectly at home. Read more at govinfonow.com/recall/58808-atrium-medical-express-mini-500-dry-seal-chest-drain-recall.
“Atrium Medical Express Mini 500 Dry Seal Chest Drain Recall: Inadequate Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58808-atrium-medical-express-mini-500-dry-seal-chest-drain-recall. Based on FDA recall #Z-1303-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2023%22&limit=1).
The FDA announced on March 1, 2023, that Atrium Medical Corporation is recalling the Express Mini 500 Dry Seal Chest Drain, Part Number 16400. The agency stated the recall addresses insufficient precautions in the Instructions for Use regarding device draining and use outside healthcare settings.
How to tell if you have it
Brand: Atrium Medical
Product: Express Mini 500 Dry Seal Chest Drain
Part Number: 16400
UDI-DI: 00650862164008
The hazard
According to the FDA, the Instructions for Use for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. The records also state that the IFUs lack sufficient precaution or warning against using the device outside the healthcare setting.
Context
GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since November 22, 2017. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (August 7, 2026), AVID Medical Halyard Arteriogram Recall (November 14, 2025), and Arrow Medical Drainage Kits Recall (April 21, 2026).
How to tell if you have this one
Check for the product name 'Express Mini 500 Dry Seal Chest Drain' with Part Number 16400. The device was manufactured 3 years before the recall started, and specific lot numbers are listed in the recall notice.
Brand
Atrium Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.
Review the Instructions for Use (IFU) to confirm if the device is safe for home use. If the IFU lacks warnings about home use, stop using it immediately.
Contact Manufacturer
Reach out to Atrium Medical Corporation for guidance on whether the device can be safely used at home or if it needs to be returned.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1303-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1303-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.