Z-1881-2024Class II

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979

Name: Z-1881-2024 SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979
Creator: Ethicon, Inc.
Published: 2024-04-23
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2024-04-23 / Open, Classified

FDA source

Ethicon, Inc. began a recall of SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979 on 2024-04-23. FDA classified it as Class II and gives the reason as "Some applicator tips from these lots had open seals". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1881-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-23
Posted: 2024-05-22
Recalling firm: Ethicon, Inc
Product: SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
Reason for recall: Some applicator tips from these lots had open seals.
FDA root cause: Under Investigation by firm
Action: On April 19, 2024 Urgent Medical Device Recall (Removal) letters were distributed to distributors and customers. Actions to be taken by customer: 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. 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 2) confirming receipt of this notice and fax or email to Sedgwick at 844-656-8030 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 SURGIFOAM" Absorbable Gelatin Powder Kits subject to this recall that are in inventory immediately. To receive credit, customers must return product subject to this recall no later than July 31, 2024. The entire kit must be returned. Any non-affected product and any product returned after the date specified will not receive credit. 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 866-912-8413. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assista
Quantity in commerce: 5,184 units
Distribution: US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI.
Product codes and lots: Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1881-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1881-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-22

Product code LMF

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)