Class II — Potential Health Hazard

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

Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART Recalled by Cook Incorporated Due to Packaging may have low seal strength and not...

Date: March 1, 2024
Company: Cook Incorporated
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 Cook Incorporated directly.

Affected Products

Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338

Quantity: 6,178 units

Why Was This Recalled?

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cook Incorporated

Cook Incorporated has 64 total recalls tracked by RecallDetector.

Related Recalls

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