FDA Medical Device Recalls (openFDA)
Ethicon Endo Surgery, LLC: PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
- Recall number
- Z-1513-2025
- Recalling firm
- Ethicon Endo Surgery, LLC
- Product
- PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
- Status
- Open, Classified
- Initiated
- 2025-03-07
- Posted
- 2025-04-03
- Terminated
- not on file
- Reason
- Identified curing issues with the silicone during the needles manufacturing process.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 792 units
- Distribution
- 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.
- Lot, serial or model codes
- Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
- 510(k) numbers
- ["K183183"]
- PMA numbers
- not on file
- Product code
- NEW
- Firm FEI
- 3005075853
- Firm city
- Guaynabo
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28