FDA Medical Device Recalls (openFDA)
Ethicon Sarl, a Johnson & Johnson Company: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
- Recall number
- Z-2407-2024
- Recalling firm
- Ethicon Sarl, a Johnson & Johnson Company
- Product
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
- Status
- Open, Classified
- Initiated
- 2024-06-11
- Posted
- 2024-07-17
- Terminated
- not on file
- Reason
- Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
- Root cause
- Process control
- Action
- On Jun 11, 2024, URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have the lot numbers from the product codes listed in Attachment 1 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. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 855-207-8799 or ethicon8137@sedgwick.com 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 return unused SURGICEL" FIBRILLAR" Absorbable Hemostat subject to this recall that are in inventory immediately. Credit will be issued to customers who ordered directly from Ethicon. Credit or replacement product as appropriate will be provided to customers who ordered through a distributor. To receive credit or replacement product, customers must return product subject to this recall no later than September 30, 2024. Any non-affected product and any product returned after the date specified will not be eligible for credit or replacement product. 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. Extra shipping labels may be obtained by calling Sedgwick at 855-620-5696. Your account number and ma
- Quantity
- 39,010 units (All US)
- Distribution
- Worldwide distribution - US Nationwide and the countries of India and Japan.
- Lot, serial or model codes
- Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMG
- Firm FEI
- 3003702646
- Firm city
- Neuchatel
- Firm state
- not on file
- Firm country
- Switzerland
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