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...
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
About Richard Wolf Medical Instruments Corp.
Richard Wolf Medical Instruments Corp. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report