MedWatch Forms for FDA Safety Reporting
OFFICIAL-SOURCE RECALL · UNITED STATES
What is an Early Alert? Recall: Early Alerts minimize time between FDA’s initial
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- What is an Early Alert?
- Manufacturer
- See official notice
- Lot number
- sExpected, sValid
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication
Hazard
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication
Official recall notice
What is an Early Alert?
Agency: FDA MedWatch
Official publication date: September 29, 2025
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