Class II — Potential Health Hazard

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

Conical portio adapter (acorn) small & large are used for Recalled by Richard Wolf Medical Instruments Corp. Due to The distal end of the Conical portio adapter...

Date: May 19, 2016
Company: Richard Wolf Medical Instruments Corp.
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 Richard Wolf Medical Instruments Corp. directly.

Affected Products

Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

Quantity: Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces

Why Was This Recalled?

The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.

Where Was This Sold?

This product was distributed to 26 states: AL, AK, AZ, AR, CA, CT, FL, GA, IL, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, TX, UT, VA, DC

Affected (26 states)Not affected

About Richard Wolf Medical Instruments Corp.

Richard Wolf Medical Instruments Corp. has 9 total recalls tracked by RecallDetector.

Related Recalls

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