Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1338-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle

Product Classification:

Class II

Date Initiated: January 10, 2018

Date Posted: April 18, 2018

Recall Number: Z-1338-2018

Event ID: 79541

Reason for Recall:

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

Status: Terminated

Product Quantity: 7020

Code Information:

Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459

Distribution Pattern:

Distribution US Nationwide, Canada, India, and Colombia.

Voluntary or Mandated:

Voluntary: Firm initiated