CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report
Surgifoam" Absorbable Gelatin Powder Kit, Product recalled by Ethicon
Ethicon is recalling Surgifoam" Absorbable Gelatin Powder Kit, distributed nationwide in the US. The recall was initiated on 23 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1881-2024
- FDA event ID
- 94496
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2024
- FDA classified
- 22 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 23 Apr 2024 | Recall initiated by company | |
| 22 May 2024 | Classified by FDA | +29 days |
| 29 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some applicator tips from these lots had open seals.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Where it was distributed
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.
Nationwide ArkansasCaliforniaFloridaGeorgiaIdahoIllinoisIndianaKentuckyMassachusettsMarylandMinnesotaMissouriNorth CarolinaNebraskaNew JerseyPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Some applicator tips from these lots had open seals.
Which lots are affected?
Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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