CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Conical portio adapter (acorn) small & large are used recalled

Richard Wolf Medical Instruments is recalling Conical portio adapter (acorn) small & large are used for examination and diagnosis in, distributed in 26 states. The recall was initiated on 19 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922

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

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2608-2016
FDA event ID: 74656
Recalling firm: Richard Wolf Medical Instruments, Vernon Hills, IL
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2016
FDA classified: 19 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

19 May 2016	Recall initiated by company
19 Aug 2016	Classified by FDA	+92 days
31 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Alaska Alabama Arkansas Arizona California Connecticut District of Columbia Florida Georgia Iowa Illinois Kentucky Massachusetts Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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