CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
Sertera Biopsy Device-intended to obtain percutaneous core recalled
Hologic is recalling Sertera Biopsy Device-intended to obtain percutaneous core biopsy samples from soft, distributed nationwide in the US. The recall was initiated on 2 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2035-2023
- FDA event ID
- 92357
- Recalling firm
- Hologic, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2023
- FDA classified
- 29 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 May 2023 | Recall initiated by company | |
| 29 Jun 2023 | Classified by FDA | +58 days |
| 5 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Product as listed by the FDA
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Which lots are affected?
UDI-DI: 15420045504066 Lot Number: E22H19RM
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hologic
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3dimensions Mammography System recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Selenia Dimensions Mammography Systems recalled by Hologic | Hologic | Other | Nationwide |
| Device | CLASS II | Genius" Review Station Display (Barco Monitor) recalled by Hologic | Hologic | Device Malfunction | Nationwide |
| Device | CLASS II | Aptima HPV Assay recalled by Hologic | Hologic | Potency & Assay | Nationwide |
| Device | CLASS II | Brevera Breast Biopsy System Disposable Needle recalled by Hologic | Hologic | Particulate Matter | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |