Surgical Hemostatic Device Recalled for Compromised Sterile Barrier
Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall involving a compromised sterile barrier on a surgical medical device. While no illnesses or injuries have been reported, the breach of sterile packaging creates a risk of contamination and infection, fitting the criterion for a High severity score as a risk-of-harm product without reported injury.
Plain-English summary
Ethicon Sarl, a Johnson & Johnson Company, is recalling SURGICEL FIBRILLAR 1IN×2IN (Product Number 1961), an absorbable surgical hemostatic agent used during surgical procedures. The recall involves approximately 450,793 units distributed worldwide, including 65,950 units in the United States.
The product is being recalled because some foil pouches were found torn open, which compromises the sterile barrier. This defect was traced to a specific machine used during product packaging. A compromised sterile barrier may allow contamination of the sterile product.
The recall affects products distributed in the United States, India, and Japan. Affected lot numbers include TFB9151, TEB6531, TFB8781, TEB6861, and many others, as specified by the manufacturer and FDA.
The recalled product
- Product
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
- Manufacturer
- Ethicon Sarl, a Johnson & Johnson Company
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Number: 1961
- UDI/DI: 10705031003118 (primary)
- 20705031003115 (box of 10)
- Lot numbers: TFB9151
- TEB6531
- TFB8781
- TEB6861
- TEB6511
- SKE2201
- SKE2101
- TDB5981
- SLE4411
- TEB7821
- TGB9291
- SBB2291
- TEB6411
- TEB7071
- TBB2481
- TBB2491
- TCB4081
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ethicon Sarl, a Johnson & Johnson Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ethicon Sarl, a Johnson & Johnson Company
See all →- HighSurgical Product Recalled Due to Torn Pouches Compromising Sterile Barrier
FDA (Devices) · 2024-07-24
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