🔍 RecallPedia

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Class I - Dangerous
🏥 Medical Devices Recalled: June 11, 2024 Ethicon Sarl, a Johnson & Johnson Company Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ethicon Sarl, a Johnson & Johnson Company
Reason for Recall:
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Product Codes/Lot Numbers:

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, TCB3751, TCB3781, TEB7211, TEB6871, TEB7601, TEB6521, TCB3351, SJE0361, TCB4071, TCB4481, TCB2931, TFB8381, TGB9801, TBB1511, SJE0241, SDB5001, RPE3591, RPE3181, RME2541, TBB1661, TCB4061, TCB4471, TCB4051, SKE2111, SKE1811, SKE1791, SJB9871, SJE0231, SHB9841, TJE1191, TDB5991, TGB9301, TDB5611, TDB5621, TFB8361, SKE1781, SKE1801, TFB8001, TFB8371, TJE1201, TCB3341, TDB5631, TDB5151, TDB6001;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2406-2024

Related Recalls