ETHICON MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for recall — FDA Z-0487-2025
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Overview of recall records associated with Ethicon, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 9.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
This page summarizes recall records in which the official source identifies Ethicon, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.