Medline medical convenience kits recalled due to potential sterility issues
Medline is recalling certain medical procedure convenience kits that contain recalled catheters with potential sterility issues. Affected kits may pose infection risks if used improperly.
Lower-risk recall
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Contact the company
What happened, in plain English
Medline is recalling medical procedure convenience kits that include specific catheters previously recalled for sterility concerns. Using these kits could lead to infection risks if the catheters are not properly sterilized. Read more at govinfonow.com/recall/53154-medline-medical-convenience-kits-recalled-due-to-potential-sterility-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/53154-medline-medical-convenience-kits-recalled-due-to-potential-sterility-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1173-2025
Cite this page
“Medline medical convenience kits recalled due to potential sterility issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53154-medline-medical-convenience-kits-recalled-due-to-potential-sterility-issues. Based on FDA recall #Z-1173-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2025%22&limit=1).
Why it’s dangerous
The kits contain catheters that were previously recalled due to potential sterility issues. If these catheters are not properly sterilized, they could cause infections during medical procedures.
Who’s affected
Healthcare providers and medical facilities that use these kits are most at risk. Patients using the kits may face infection risks if the catheters are not properly sterilized.
How to tell if you have this one
Check for the model number DUNJ63397 on the kit. Lot numbers 22HLA247, 21HLA443, 21JLA520, and 22GLA335 are also affected.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Kit Model
Verify the model number on the kit is DUNJ63397.
Review Lot Numbers
Check if the kit has lot numbers 22HLA247, 21HLA443, 21JLA520, or 22GLA335.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “US: CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1173-2025 (January 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1173-2025 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.