Ethicon Endo Surgery, LLC: Medical Device Recall in 2025 - (Recall #: Z-1515-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

Product Classification:

Class II

Date Initiated: March 7, 2025

Date Posted: April 9, 2025

Recall Number: Z-1515-2025

Event ID: 96461

Reason for Recall:

Identified curing issues with the silicone during the needles manufacturing process.

Status: Ongoing

Product Quantity: 37,080 units

Code Information:

Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER;

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated