Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM Recalled by Ethicon Endo Surgery, LLC Due to Identified curing issues with the silicone during the...

Date: March 7, 2025
Company: Ethicon Endo Surgery, LLC
Status: Ongoing
Source: FDA (Device)

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 Ethicon Endo Surgery, LLC directly.

Affected Products

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Quantity: 37,080 units

Why Was This Recalled?

Identified curing issues with the silicone during the needles manufacturing process.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ethicon Endo Surgery, LLC

Ethicon Endo Surgery, LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report