Overview of recall records associated with Ethicon, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 55.
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
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative…
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may…
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament…
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
The product does not meet certain internal strength testing specifications.
The product does not meet certain internal strength testing specifications.
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
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.
