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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.

CountryUnited StatesPublishedSeptember 29, 2025Last updatedSeptember 29, 2025Official source last checkedAugust 29, 2026 at 9:56 AM UTC

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Is your product affected?

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Product
What is an Early Alert?
Manufacturer
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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

Read the official FDA recall notice →

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