Ethicon, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2146-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

Product Classification:

Class II

Date Initiated: May 10, 2024

Date Posted: June 26, 2024

Recall Number: Z-2146-2024

Event ID: 94643

Reason for Recall:

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Status: Ongoing

Product Quantity: 56952 units

Code Information:

GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Distribution Pattern:

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Voluntary or Mandated:

Voluntary: Firm initiated