Fresen: Stay Safe Cap Labeling Update for Safety Warnings
Fresenius Medical Care recalls Stay Safe Cap model 050-95012 due to labeling updates needed for safety warnings. All lots affected.
Lower-risk recall
Updating the labeling to include additional warnings and contraindications for potential side effects.
Contact the company
What happened, in plain English
Fresenius Medical Care is recalling Stay Safe Cap model 050-95012 because updated labeling is required for safety warnings. This affects all units produced. The recall is for labeling improvements to prevent potential side effects. Read more at govinfonow.com/recall/57105-fresen-stay-safe-cap-labeling-update-for-safety-warnings.
Source Summary by GovInfoNow · govinfonow.com/recall/57105-fresen-stay-safe-cap-labeling-update-for-safety-warnings · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0507-2024
Cite this page
“Fresen: Stay Safe Cap Labeling Update for Safety Warnings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57105-fresen-stay-safe-cap-labeling-update-for-safety-warnings. Based on FDA recall #Z-0507-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0507-2024%22&limit=1).
Why it’s dangerous
The device requires updated labeling to include warnings about potential side effects. Without these updates, users might not be aware of risks that could lead to adverse reactions.
Who’s affected
Patients using the Stay Safe Cap device are affected. Those with medical conditions requiring specific labeling updates are at higher risk.
How to tell if you have this one
Check for the model number 050-95012 on the Stay Safe Cap. All lots of this product are affected by the recall.
- Brand
Fresenius Medical Care- Category
Medical device
What to do — step by step
Review Labeling Updates
Check if the device has updated labeling with additional warnings and contraindications for potential side effects.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months 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-0507-2024 (October 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0507-2024 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.