Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Hologic, Inc
- Reason for Recall:
- Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Product Codes/Lot Numbers:
Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1170-2025
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