Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Peel Away Sheath over Dilator Recalled by Arrow International Inc Due to Product sterility may be compromised due to unsealed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
Quantity: 416,055 total products
Why Was This Recalled?
Product sterility may be compromised due to unsealed packaging.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report