Medline Sterile Povidone Iodine Sponges Recall: Packaging Seal Risk
Medline recalls custom convenience kits with Sterile Pre-Saturated Povidone Iodine Sponge Products due to potential voids in packaging seals that could compromise sterility. Affected kits include specific part numbers and lot numbers listed in the recall.
Lower-risk recall
Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
Contact the company
What happened, in plain English
Medline is recalling custom convenience kits containing sterile povidone iodine sponge products because the packaging seals might have voids, risking loss of sterility. This could lead to infections if the sponges are used improperly. Read more at govinfonow.com/recall/65697-medline-sterile-povidone-iodine-sponges-recall-packaging-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65697-medline-sterile-povidone-iodine-sponges-recall-packaging-seal-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2040-2020
Cite this page
“Medline Sterile Povidone Iodine Sponges Recall: Packaging Seal Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/65697-medline-sterile-povidone-iodine-sponges-recall-packaging-seal-risk. Based on FDA recall #Z-2040-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2040-2020%22&limit=1).
Why it’s dangerous
The packaging seal may have voids, which could allow loss of sterility on the outside of the foil pouch. This means the sponges might not be sterile when used, increasing infection risk during medical procedures.
Who’s affected
Healthcare professionals and surgical teams who use these kits are most at risk. Patients using the sponges during procedures may be affected if the sterility is compromised.
How to tell if you have this one
Check for specific part numbers listed in the recall (e.g., DYNJ906478, DYNJ30056J) and associated lot numbers (e.g., 19HDC844, 19JDC085). The kits are labeled with the part descriptions and part numbers.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Your Kit
Look for the specific part numbers and lot numbers listed in the recall to determine if your kit is affected.
Contact Medline
Reach out to Medline directly for assistance with the recall process and to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 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-2040-2020 (March 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2040-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.