SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979 recallZ-1881-2024 · Ethicon, Inc. · initiated Apr 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some applicator tips from these lots had open seals.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1881-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 23, 2024
- Posted by the FDA
- May 22, 2024
- Recalling firm
- Ethicon, Inc.
- Quantity
- 5,184 units
- Product code
- LMF
- FDA submissions
- P990004
- 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 description
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Code information (models, lots, serial numbers)
Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SURGIFOAM® Absorbable Gelatin Powder Kit 1979Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall2 reports
Other devices under the same FDA submission
10 devices cleared under P990004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 recall42 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1972Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based24 reports
- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1974Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Powder 1978Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based2 reports
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge 1969Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1973Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 death1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. 1975Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Hemorrhoidectomy Sponge 1977Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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