Reported Feb 19, 2025 · Ongoing
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- Brand NameSertera
- Biopsy Device Product NameSertera
- Biopsy Device Model/Catalog NumberSertera-14
- Software VersionN/A
- Product DescriptionInstrument
- Biopsy ComponentN/A
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 Model No- Sertera-14 2 15420045504066UDI- 15420045504066 3 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 - Amount recalled
- 55,335 units
Where it was sold
- Nationwide
Why it was recalled
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
This product could cause temporary or reversible health problems — stop using it.
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