- Recalling firm
- Ethicon, LLC
- Reason for recall
- Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
- Affected products (lot / model / serial)
- UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026
- Units affected
- 1764
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
- Firm location
- San Lorenzo, PR, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0153-2027
- Recall initiated
- September 8, 2026
- FDA classification date
- October 14, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99754
- Last updated on HTM Vibe
- October 27, 2026
