Medline RevMedX Trauma Dressings: Package Seal Integrity Risk
Medline recalls RevMedX Trauma Dressings due to potential package seal issues that may compromise sterility. Affected items include specific lot numbers from August 2022 to May 2023.
Lower-risk recall
RevMedX Trauma Dressing is being recalled due to package seal integrity.
Contact the company
What happened, in plain English
Medline is recalling RevMedX Trauma Dressings because the packaging may not seal properly, risking contamination. This could lead to infection if the dressings are used without proper sterility. Read more at govinfonow.com/recall/63981-medline-revmedx-trauma-dressings-package-seal-integrity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63981-medline-revmedx-trauma-dressings-package-seal-integrity-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0615-2021
Cite this page
“Medline RevMedX Trauma Dressings: Package Seal Integrity Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63981-medline-revmedx-trauma-dressings-package-seal-integrity-risk. Based on FDA recall #Z-0615-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2021%22&limit=1).
Why it’s dangerous
The package seal may not hold properly, potentially allowing contamination. This could compromise the sterility of the dressings, increasing infection risk during medical procedures.
Who’s affected
Healthcare professionals and individuals using these dressings for trauma care. Those with the specific lot numbers listed are most at risk.
How to tell if you have this one
Check for lot numbers 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; or 38218050002, 05/2023 on the packaging.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Package Seal
Inspect the Tyvek Peel pouch for any signs of damage or improper sealing.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.” 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 terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0615-2021 (November 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0615-2021 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.