Z-2407-2024Class II

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

Name: Z-2407-2024 SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Creator: Ethicon Sarl, a Johnson & Johnson Company
Published: 2024-06-11
License: https://open.fda.gov/license/

Ethicon SARL / initiated 2024-06-11 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon Sarl, a Johnson & Johnson Company began a recall of SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963 on 2024-06-11. FDA classified it as Class II and gives the reason as "Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2407-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-11
Posted: 2024-07-17
Recalling firm: Ethicon SARL
Product: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Product code: LMG Agent, Absorbable Hemostatic, Non-Collagen Based
Reason for recall: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 39,010 units (All US)
Distribution: Worldwide distribution - US Nationwide and the countries of India and Japan.
Product codes and lots: Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2407-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17
Z-2407-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code LMG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)