Recall Z-1515-2025— Ethicon Endo Surgery, LLC

Name: FDA recall Z-1515-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-07

Class II · Ongoing

Class II FDA medical device recall by Ethicon Endo Surgery, LLC, initiated 2025-03-07. It names one FDA 510(k) clearance: K133356. Product: PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM. Reason: Identified curing issues with the silicone during the needles manufacturing process..

Recalling firm: Ethicon Endo Surgery, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-07
Firm location: Guaynabo, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K133356 — PROLENE POLYPROPYLENE NONABSORBABLE SUTUREETHICON, Inc.·cleared 2013-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.