Class II — Potential Health Hazard

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

Plain and Chromic Gut Absorbable Surgical Sutures Recalled by CP Medical Inc Due to Potential compromise of product sterility after routine monitoring...

Date: February 4, 2019
Company: CP Medical Inc
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 CP Medical Inc directly.

Affected Products

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

Quantity: 1,905 boxes (22,860 sutures total)

Why Was This Recalled?

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CP Medical Inc

CP Medical Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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