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Hologic, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000045852 FEI 1000120743

Hologic, Inc. is a medical device manufacturer based in the United States, with 120 devices listed in 4 registries (FDA Class II, III and I) and 64 FDA recalls as of 13 Nov 2026.

Devices
120
Registrations
EUDAMEDFDA
FDA recalls
6422 ongoing since 2021 (23 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 102
  • FDA PMA 18
  • FDA GUDID 5
  • EUDAMED 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 108
  • FDA Class III 9
  • FDA Class I 1
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000045852
  • FDA FEI 1000120743
  • DUNS 018925968

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
Hologic BVBE

What Hologic, Inc. makes

Hologic manufactures digital stationary mammographic X-ray systems for breast imaging, including biopsy systems like the Brevera Breast Biopsy System, and implantable radiological image markers such as SecurMark for ATEC. The company also produces laboratory instruments and software for in vitro diagnostics (IVD), including nucleic acid testing kits for sexually transmitted pathogens (e.g., Aptima® and Panther Fusion®) and exogenous DNA/RNA internal controls. Optical medical devices like the rigid optical hysteroscope (ATEC) and specimen radiography systems (e.g., TRIDENT HD) are part of its portfolio, alongside microscope slide preparation tools (e.g., ThinPrep).

Hologic’s devices are regulated under FDA’s Unique Device Identification (UDI) system and fall into Class I, Class II, and Class III classifications depending on risk level. The company is headquartered in the United States, with its products listed in the FDA’s UDI database.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue120

Newest first, rows 1-50 of 120

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Rows 1-50 of 120

Showing 1-50 of 120

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000045852
FDA FEI number
1000120743
DUNS number
018925968
EUDAMED status
Active
EUDAMED registered name
Hologic, Inc.
EUDAMED abbreviated name
Hologic, Inc. BRST Surgery
Registered address
250, Campus Drive, 01752, Marlborough, United States
Phone
+1(800)442-9892
PRRC contact
Marissa Richmond(public in EUDAMED)

FDA recalls64

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 63 recalls initiated by Hologic, Inc., the earliest on 2008-06-27 and the most recent on 2026-04-08. By recorded status: 23 ongoing, 39 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, mechanical integrity and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 5
  • 2018 2
  • 2019 1
  • 2020 2
  • 2021 1
  • 2022 4
  • 2023 4
  • 2024 6
  • 2025 4
  • 2026 4

31 initiated before 2017

Showing the 10 most recent of 64 recalls.

  • 2026

    • 8 Apr 2026 Z-2167-2026 Class II Ongoing Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Distribution: US Nationwide distribution. Submission number: P010025
    • 8 Apr 2026 Z-2168-2026 Class II Ongoing Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Distribution: US Nationwide distribution. Submission number: P080003
    • 23 Mar 2026 Z-1949-2026 Class II Ongoing It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual. Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
    • 18 Feb 2026 Z-1586-2026 Class II Ongoing Due to product exhibiting potential to generate either invalid or false negative results. Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. Submission number: P100042

  • 2025

    • 15 Dec 2025 Z-1314-2026 Class II Ongoing Presence of particulates in affected devices that can be deposited into breast tissue during use. Distribution: US Nationwide distribution. Submission number: K163052
    • 12 Dec 2025 Z-1093-2026 Class II Ongoing Fungal contamination of affected lot with Parengyodontium album. Distribution: US Nationwide distribution.
    • 15 Jan 2025 Z-1170-2025 Class II Ongoing Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. Distribution: Domestic: Nationwide Distribution Submission number: K150169
    • 8 Jan 2025 Z-1095-2025 Class II Ongoing Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Guam and the countries of Canada and Japan.
      Submission number: K900225

  • 2024

    • 13 Dec 2024 Z-0907-2025 Class II Ongoing Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. Distribution: AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada. Submission number: K181156
    • 8 Nov 2024 Z-0694-2025 Class II Ongoing SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. Distribution: US: AK Submission number: K222736
Show the 25 most recent of 64 recalls

  • 2024

    • 10 Oct 2024 Z-0328-2025 Class I Ongoing Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. Distribution: Domestic: US Nationwide Distribution. Submission numbers: K143484, K152070
    • 19 Aug 2024 Z-3248-2024 Class II Ongoing Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands. Submission number: P080003
    • 13 Jun 2024 Z-2373-2024 Class II Ongoing Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability. Distribution: Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, Andorra, Switzerland, Taiwan, Austria, Korea, Republic of Philippines, Kuwait, Slovakia, China, Belgium, Ireland, United Kingdom, Malaysia, Palestinian Territory, Occupied, Peru, Singapore, Qatar, Algeria, Pakistan, New Zealand, Croatia, Brazil, Bangladesh, Saudi Arabia, Venezuela, Israel, Lebanon, Nepal, Romania, Greece, Hong Kong, Morocco, Indonesia, Cyprus, Jordan, France, Mexico, Colombia, Iran, Islamic, Republic of Chile, Turkey, Uruguay, Viet Nam, Serbia, Poland, Japan, Malta, Netherlands, South Africa.
      Submission number: K023398
    • 13 Mar 2024 Z-1733-2024 Class I Ongoing Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device Distribution: US Nationwide Distribution Submission number: K152070

  • 2023

    • 15 Dec 2023 Z-0782-2024 Class II Ongoing Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, UT, VA, VI, WA, WI, and WV. The countries of Austria, Australia, Belgium, Dominican Republic, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Ireland, Italy, Korea, Kuwait, The Netherlands, Norway, New Zealand, Portugal, Qatar, and Sweden.
    • 14 Sep 2023 Z-1371-2024 Class II Ongoing Use of assay along with plasma specimen may result in error code which would invalidate sample. Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
    • 2 May 2023 Z-2035-2023 Class II Ongoing The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery Distribution: US Nationwide distribution. Submission number: K150169
    • 16 Jan 2023 Z-1144-2023 Class II Ongoing C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual Distribution: US Nationwide distribution. Submission number: P080003

  • 2022

    • 10 Oct 2022 Z-0669-2025 Class II Completed IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set Distribution: US Nationwide distribution.
    • 9 Aug 2022 Z-1858-2022 Class II Ongoing Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date. Distribution: US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO,…
      Full distribution text US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA.
      Submission number: K152070
    • 18 Mar 2022 Z-0877-2022 Class II Ongoing Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. Distribution: US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA Submission number: K181156
    • 27 Jan 2022 Z-0750-2022 Class II Ongoing Failed stability specifications for reagent kits that may result in false negative test results. Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.

  • 2021

    • 26 Feb 2021 Z-1369-2021 Class II Ongoing There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).

  • 2020

    • 4 Aug 2020 Z-2990-2020 Class II Terminated Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay. Distribution: U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA,…
      Full distribution text U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
    • 21 Jan 2020 Z-1343-2020 Class II Terminated The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. Distribution: Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution…
      Full distribution text Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.
      Submission numbers: P080003, P010025S013

Frequently asked questions

How many devices does Hologic, Inc. have in the registry?

The registry currently lists 120 devices for Hologic, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hologic, Inc.'s devices?

Among its 50 most recently registered devices, Hologic, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Hologic, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Hologic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Hologic, Inc.?

FDA recall records list 64 recalls initiated by Hologic, Inc., the most recent initiated on 8 Apr 2026. 23 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Hologic, Inc. in the registry?

The most recently registered devices listed for Hologic, Inc. include Panther Fusion Paraflu Assay, CONTRAST ENHANCED DIGITAL MAMMOGRAPHY, Genius AI Detection 2.0 and Aptima Neisseria gonorrhoeae Assay.

Generated automatically from registry data and not verified by a human reviewer.