--- title: "Hologic, Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Hologic, Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/hologic-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Hologic, Inc recall records **21** reported ongoing 22 records in this archive. Latest source date Apr 8, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 8, 2026 FDA device enforcement ### [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-000...](https://isitonrecall.com/recall/fda-device-z-2167-2026-selenia-dimensions-mammography-systems-model-numbers-sda-sys-3000-2d-htc-sda-sys-3000-3d-sdm-sys-600/) Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2167-2026%22) Apr 8, 2026 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-2168-2026-3dimensions-mammography-system-model-numbers-3dm-sys-intl2d-3dm-sys-intl2d-mob-3dm-sys-intl2d-ns-3dm/) Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2168-2026%22) Mar 23, 2026 FDA device enforcement ### [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 spec...](https://isitonrecall.com/recall/fda-device-z-1949-2026-brand-name-genius-review-station-product-name-genius-review-station-display-barco-monitor-model-cata/) 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 (AA... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East. [Official source for Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) M...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1949-2026%22) Feb 18, 2026 FDA device enforcement ### [Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No](https://isitonrecall.com/recall/fda-device-z-1586-2026-brand-name-aptima-hpv-assay-product-name-aptima-hpv-assay-model-catalog-number-303585-product-descri/) Due to product exhibiting potential to generate either invalid or false negative results. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN. [Official source for Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1586-2026%22) Dec 15, 2025 FDA device enforcement ### [Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.](https://isitonrecall.com/recall/fda-device-z-1314-2026-brevera-breast-biopsy-system-disposable-9-gauge-needle-biopsy-instrument/) Presence of particulates in affected devices that can be deposited into breast tissue during use. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1314-2026%22) Dec 12, 2025 FDA device enforcement ### [ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.](https://isitonrecall.com/recall/fda-device-z-1093-2026-thinprep-cytolyt-solution-buffered-cell-wash-solution/) Fungal contamination of affected lot with Parengyodontium album. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1093-2026%22) Jan 15, 2025 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-1170-2025-brand-name-sertera-biopsy-device-product-name-sertera-biopsy-device-model-catalog-number-sertera-14/) Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. Class II Reported ongoing Distribution: Domestic: Nationwide Distribution [Official source for Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Serte...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1170-2025%22) Jan 8, 2025 FDA device enforcement ### [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 manufactur...](https://isitonrecall.com/recall/fda-device-z-1095-2025-the-rapid-ffn-specimen-collection-tube-pn-71550-001-is-a-component-of-the-rapid-ffn-specimen-collect/) 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 Im... Class II Reported ongoing 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,... [Official source for The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1095-2025%22) Dec 13, 2024 FDA device enforcement ### [Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.](https://isitonrecall.com/recall/fda-device-z-0907-2025-panther-fusion-gbs-assay-ref-prd-04484-kit-containing-panther-fusion-gbs-reagent-cartridge-ivd/) Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. Class II Reported ongoing Distribution: AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada. [Official source for Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0907-2025%22) Nov 8, 2024 FDA device enforcement ### [Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400](https://isitonrecall.com/recall/fda-device-z-0694-2025-panther-fusion-sars-cov-2-flu-a-b-rsv-assay-ref-prd-07400/) SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. Class II Reported ongoing Distribution: US: AK [Official source for Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0694-2025%22) Oct 10, 2024 FDA device enforcement ### [BioZorb Marker. Radiographic soft tissue marker.](https://isitonrecall.com/recall/fda-device-z-0328-2025-biozorb-marker-radiographic-soft-tissue-marker/) Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. Class I Reported ongoing Distribution: Domestic: US Nationwide Distribution. [Official source for BioZorb Marker. Radiographic soft tissue marker.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0328-2025%22) Aug 19, 2024 FDA device enforcement ### [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-168...](https://isitonrecall.com/recall/fda-device-z-3248-2024-selenia-dimensions-3dimensions-digital-breast-tomosynthesis-software-version-dimensions-1-12-0-and-3/) 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... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands. [Official source for Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 a...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3248-2024%22) Jun 13, 2024 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-2373-2024-horizon-x-ray-bone-densitometer-dxa-models-horizon-a-horizon-w-horizon-wi-horizon-c-horizon-ci-horiz/) 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 exc... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, And... [Official source for Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2373-2024%22) Mar 13, 2024 FDA device enforcement ### [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) ...](https://isitonrecall.com/recall/fda-device-z-1733-2024-biozorb-marker-biozorb-3d-bioabsorbable-marker-intended-use-radiographic-marking-of-sites-in-soft-ti/) 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 ... Class I Reported ongoing Distribution: US Nationwide Distribution [Official source for BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1733-2024%22) Dec 15, 2023 FDA device enforcement ### [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 samp...](https://isitonrecall.com/recall/fda-device-z-0782-2024-panther-fusion-system-ref-9121010000-the-panther-system-is-an-integrated-nucleic-acid-testing-system/) Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Class II Reported ongoing 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, ... [Official source for PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing sys...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0782-2024%22) Sep 14, 2023 FDA device enforcement ### [Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Sol...](https://isitonrecall.com/recall/fda-device-z-1371-2024-aptima-cmv-quant-assay-reference-numbers-aw-22600-001-aw-25509-001-and-aw-26381-001-amplification-re/) Use of assay along with plasma specimen may result in error code which would invalidate sample. Class II Reported ongoing 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... [Official source for Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplifica...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1371-2024%22) May 2, 2023 FDA device enforcement ### [Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14](https://isitonrecall.com/recall/fda-device-z-2035-2023-sertera-14-gauge-biopsy-device-intended-to-obtain-percutaneous-core-biopsy-samples-from-soft-tissue/) The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tiss...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2035-2023%22) Jan 16, 2023 FDA device enforcement ### [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 SD...](https://isitonrecall.com/recall/fda-device-z-1144-2023-hologic-3dimensions-selenia-dimensions-models-rm-sdm-00001-3d-sdm-00001-2d-sdm-00001-3d-sdm-05000-3d/) C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-0500...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1144-2023%22) Oct 10, 2022 FDA device enforcement ### [Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101](https://isitonrecall.com/recall/fda-device-z-0669-2025-hologic-sizer-set-sterilization-tray-and-6-individual-sizers-intended-as-a-surgical-instrument-guide/) IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set Class II Reported completed Distribution: US Nationwide distribution. [Official source for Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0669-2025%22) Aug 9, 2022 FDA device enforcement ### [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 (poly...](https://isitonrecall.com/recall/fda-device-z-1858-2022-the-biozorb-lp-marker-is-an-implantable-radiopaque-marker-used-to-facilitate-visualization-of-a-soft/) 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 diff... Class II Reported ongoing 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. [Official source for The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a s...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1858-2022%22) ## Reasons in these listed records - Complaints have been received of systems developing loose, missing, or broken internal bolts over time. - 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 calibra... - Due to product exhibiting potential to generate either invalid or false negative results. - Presence of particulates in affected devices that can be deposited into breast tissue during use. These examples come from this result page and are not a ranking of every recall reason. ## Checking Hologic, Inc ### Is there a recall on hologic, inc right now? This archive contains 22 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Hologic, Inc](https://isitonrecall.com/check/?q=Hologic%2C%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)