Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM

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

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

On March 7, 2025, "URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated March 7, 2025, were sent to customers. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 866-209-0985 or email ethicon8403@sedgwick.com to Sedgwick within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to immediately return all unused sutures subject to this recall that are in inventory no later than June 30, 2025, to Sedgwick. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 866-737-4762 and reference Event # 8403. If you have additional questions regarding this communication or want to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.

• FDA enforcement recordOfficial FDA database entry for Z-1515-2025
• FDA 510(k) clearance · K133356The device's official FDA premarket clearance record
• FDA device classification · NEWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4840The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ethicon Endo Surgery, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.