San Diego, CA, United States
Hologic, Inc recalls
29 recalls recorded since 2018, most recently on 8 April 2026. 22 are listed as ongoing. Status and classification are as published by the FDA.
Recalls29
Ongoing (FDA)22
Terminated or completed7
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 8 April 2026
- Reason
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2167-2026, Z-2168-2026
- SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-0
- 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Ongoing Class II Medical devices
- Recall started
- 23 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1949-2026
- Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review
Ongoing Class II Medical devices
- Recall started
- 18 February 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1586-2026
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Presence of particulates in affected devices that can be deposited into breast tissue during use.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1314-2026
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Ongoing Class II Medical devices
- Recall started
- 12 December 2025
- Reason
- Fungal contamination of affected lot with Parengyodontium album.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1093-2026
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Ongoing Class II Medical devices
- Recall started
- 15 January 2025
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1170-2025
- 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
Ongoing Class II Medical devices
- Recall started
- 8 January 2025
- Reason
- 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, 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1095-2025
- The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnosti
Ongoing Class II Medical devices
- Recall started
- 13 December 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0907-2025
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Ongoing Class II Medical devices
- Recall started
- 8 November 2024
- Reason
- SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- Distribution
- US: AK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0694-2025
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Ongoing Class I Medical devices
- Recall started
- 10 October 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0328-2025
- BioZorb Marker. Radiographic soft tissue marker.
Ongoing Class II Medical devices
- Recall started
- 19 August 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3248-2024
- Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3
Ongoing Class II Medical devices
- Recall started
- 13 June 2024
- Reason
- 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, Thailand, Dominican Republic, Portugal, Islas Canarias, Andorra, Switzerland, Taiwan, Austria, Korea, Republic of Philippines, Kuwait, Slovakia, China, Belgium, Ireland, United Kin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2373-2024
- Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
Ongoing Class I Medical devices
- Recall started
- 13 March 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1733-2024
- BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4)
Ongoing Class II Medical devices
- Recall started
- 15 December 2023
- Reason
- 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, 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0782-2024
- PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, d
Ongoing Class II Medical devices
- Recall started
- 14 September 2023
- Reason
- 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 Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1371-2024
- Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Prom
Ongoing Class II Medical devices
- Recall started
- 2 May 2023
- Reason
- The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2035-2023
- Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Ongoing Class II Medical devices
- Recall started
- 16 January 2023
- Reason
- C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1144-2023
- Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-S
Completed Class II Medical devices
- Recall started
- 10 October 2022
- Reason
- IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0669-2025
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Ongoing Class II Medical devices
- Recall started
- 9 August 2022
- Reason
- 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, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1858-2022
- The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs comple
Ongoing Class II Medical devices
- Recall started
- 18 March 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0877-2022
- Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Ongoing Class II Medical devices
- Recall started
- 27 January 2022
- Reason
- 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, 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0750-2022
- Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Ongoing Class II Medical devices
- Recall started
- 26 February 2021
- Reason
- 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, 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 (I
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1369-2021
- Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Terminated Class II Medical devices
- Recall started
- 4 August 2020
- Terminated
- 23 December 2024
- Reason
- 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, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2990-2020
- Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Terminated Class II Medical devices
- Recall started
- 21 January 2020
- Terminated
- 11 August 2021
- Reason
- 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 to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1343-2020
- Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Ongoing Class II Medical devices
- Recall started
- 10 October 2019
- Reason
- Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
- Distribution
- US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2163-2020
- Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution),
Terminated Class II Medical devices
- Recall started
- 6 December 2018
- Terminated
- 24 April 2020
- Reason
- Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
- Distribution
- Nationwide Foreign: Australia Austria Belgium Brazil Canada China Colombia Ecuador Egypt France Germany Greece Hong Kong India Ireland Israel Italy Japan Korea, Republic of Kuwait Malaysia Mexico Netherlands Pakistan Peru Poland Portugal Saudi Arabia Singapore Slovakia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0685-2019
- I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Terminated Class II Medical devices
- Recall started
- 20 January 2018
- Terminated
- 28 July 2022
- Reason
- The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
- Distribution
- Worldwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0595-2018
- Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of n
Terminated Class II Medical devices
- Recall started
- 29 November 2017
- Terminated
- 22 August 2018
- Reason
- Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
- Distribution
- United States (US), Guam (GU), Japan (JP)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0676-2018, Z-0677-2018
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Terminated Class II Medical devices
- Recall started
- 7 July 2017
- Terminated
- 4 April 2018
- Reason
- The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
- Distribution
- US and OUS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0351-2018
- Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.