Richard Wolf Medical Instruments Corp.: Medical Device Recall in 2016 - (Recall #: Z-2608-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 19, 2016

Date Posted: August 31, 2016

Recall Number: Z-2608-2016

Event ID: 74656

Reason for Recall:

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.

Status: Terminated

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

Code Information:

Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922

Distribution Pattern:

U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.

Voluntary or Mandated:

Voluntary: Firm initiated