Stop using nowMedical device recall · FDA · Published January 28, 2022
Sam Chest Seal CS203-EN Combo: Hole in Dressing Prevents Proper Seal
Sam Medical Products recalls CS203-EN Combo chest seal lot Y060321-09 due to a hole in the dressing that prevents creating an occlusive seal over chest wounds. Affected units may not function correctly in emergencies.
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
Take action
Contact the company
📍Recalling firmSam Medical Products12200 SW Tualatin Rd Suite 200 · Tualatin, OR 97062
“Sam Chest Seal CS203-EN Combo: Hole in Dressing Prevents Proper Seal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61206-sam-chest-seal-cs203-en-combo-hole-in-dressing-prevents. Based on FDA recall #Z-0789-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0789-2022%22&limit=1).
Sam Medical Products voluntarily recalled SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 due to partially assembled valved dressings with holes that prevent proper sealing, the FDA announced on Jan. 28, 2022.
The partially assembled valved dressing contains a hole instead of the intended non-valved design, preventing it from centering over an open chest wound and creating an occlusive seal. The FDA classified this Class II recall as voluntary and firm-initiated.
Context
GovInfoNow's records show Medline issued a recall for Quick-Strip Bandages on Oct. 27, 2025, citing open packaging that may compromise sterility.
How to tell if you have this one
Check for the model CS203-EN Combo with lot number Y060321-09 on the packaging. The product was sold in case cartons and individual pouches.
Brand
Sam Medical Products
Product
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the recalled chest seal as it cannot create a proper seal over chest wounds.
Where it went and when
Where it was distributed
Distributed in 13 states and Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Georgia, Massachusetts, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-0789-2022 (January 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0789-2022 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.