Richard Wolf Conical Portio Adapter Recall Due to Weld Defect
Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters because an improper weld may cause the device to separate during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural failure (separation of components) in a medical device used during a procedure, which presents a potential risk to patients without reported fatalities or hospitalizations in the source text.
Plain-English summary
Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters (acorn) small and large. These medical devices are used in gynecological laparoscopy to examine and diagnose patients, specifically to determine the patency of the fallopian tubes. The recall affects Product code 8378.90 (94 pieces) and Product code 8378.91 (32 pieces).
The recall is due to a manufacturing defect where the distal end of the adapter, which consists of a small cap welded to a hollow shaft, was improperly joined. This improper weld means the two pieces are not securely attached, creating a risk that the components could separate during use. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The affected products were distributed to consignees in the following U.S. states and districts: 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. Healthcare providers and facilities should stop using the affected batches immediately and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Richard Wolf Medical Instruments Corp.
Distribution
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