Stay Safe Cap recall: Labeling Error
Stay Safe Cap
Why was Stay Safe Cap recalled?
Updating the labeling to include additional warnings and contraindications for potential side effects.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
- Product
- Stay Safe Cap
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 18,236,160 eaches
- Distribution
- US Nationwide distribution.
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)