Class II — Potential Health Hazard

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

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product Recalled by Ethicon, Inc. Due to The product does not meet certain internal strength...

Date: August 13, 2019
Company: Ethicon, Inc.
Status: Terminated
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, Inc. directly.

Affected Products

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Quantity: 416 each

Why Was This Recalled?

The product does not meet certain internal strength testing specifications.

Where Was This Sold?

This product was distributed to 18 states: AR, CA, CO, GA, IL, IN, KS, KY, MD, NJ, NC, OH, OK, OR, PA, TN, UT, WA

Affected (18 states)Not affected

About Ethicon, Inc.

Ethicon, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

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