Hologic, Inc recalls
Every recall we track for Hologic, Inc — 33 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Hologic, Inc peaked in 2024 (6); 33 since 2017.
All FDA recall records for Hologic, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 4 | 1 | 5 |
| 2018 | 0 | 1 | 1 | 0 | 2 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 1 | 1 | 0 | 2 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 4 | 0 | 4 |
| 2023 | 0 | 2 | 2 | 0 | 4 |
| 2024 | 0 | 3 | 3 | 0 | 6 |
| 2025 | 0 | 1 | 3 | 0 | 4 |
| 2026 (to date) | 0 | 2 | 2 | 0 | 4 |
What to do if you have a recalled Hologic, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Hologic, Inc recalls
31 shown- Use cautionMedical device
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D,
Hologic recalls SELENIA Dimensions Mammography Systems with model numbers SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, and others due to loose, missing, or broken internal bolts that could affect system stability.
HologicApr 8, 2026 - Use cautionMedical device
Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number:
Hologic recalls Genius Review Station Display (model CMP-016:01669) due to user modifications causing safety risks. Affected users should stop using modified devices until corrected.
HologicMar 23, 2026 - Lower riskMedical device
Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima
Hologic recalls Aptima HPV Assay Kit (model 303585) due to potential for false negatives. Affected kits may give incorrect results, leading to missed diagnoses. Contact Hologic for details.
HologicFeb 18, 2026 - Lower riskMedical device
Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Hologic recalls Brever: Particulates in disposable 9 gauge biopsy needles may deposit in breast tissue during use. Affected units include all lots within expiry date.
HologicDec 15, 2025 - Lower riskMedical device
Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic recalls ThinPrep CytoLyt Solution due to fungal contamination in specific lots. Affected units may pose health risks if used improperly.
HologicDec 12, 2025 - Use cautionMedical device
Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software
Hologic recalls Sertera-14 biopsy devices due to risk of inner needle separating from hub, potentially causing dislodgement. Affected units include specific model numbers and lot codes.
HologicJan 15, 2025 - Lower riskMedical device
Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN:
Hologic recalls specific lots of Rapid fFN Specimen Collection Tubes that may be empty or underfilled, causing invalid test results for preterm delivery risk assessment.
HologicJan 8, 2025 - Lower riskMedical device
Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic recalls Panther Fusion GBS Assay REF PRD-04484 Kit due to potential weak pouch seal causing invalid test results, which may delay treatment. Affected kits have specific lot numbers and expiration dates.
HologicDec 13, 2024 - Lower riskMedical device
Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Hologic recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits that may give false positive results for SARS-CoV-2. Affected kits have specific lot numbers and expiration dates.
HologicNov 8, 2024 - Use cautionMedical device
Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.
Hologic recalls BioZorb Marker radiographic soft tissue markers due to serious injuries like pain, infection, and device migration. Affected models include F0405, F0404, and others. Contact Hologic for details.
HologicOct 10, 2024 - Use cautionMedical device
Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0
Hologic recalls specific software versions for breast tomosynthesis systems that may produce blurry images when used with C-View software, potentially causing false negative diagnoses. Affected users should contact Hologic for updates.
HologicAug 19, 2024 - Lower riskMedical device
Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN,
Hologic recalls Horizon X-Ray Bone Densitometer (DXA) models Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN due to electromagnetic compatibility issues with international medical standards. Affected units have serial numbers listed in the recall notice.
HologicJun 13, 2024 - Use cautionMedical device
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405
Hologic recalls BioZorb 3D bioabsorbable markers used in breast procedures due to reported pain, infection, and device complications. Affected models include F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202.
HologicMar 13, 2024 - Lower riskMedical device
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully
Hologic recalls Panther Fusion System REF 9121010000 due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Affected units may need replacement.
HologicDec 15, 2023 - Lower riskMedical device
Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme
Hologic recalls Aptima CMV Quant Assay reagents (AW-22600-001, AW-25509-001, AW-26381-001) due to potential error codes when used with plasma specimens. Affected units may invalidate samples.
HologicSep 14, 2023 - Use cautionMedical device
Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the
Hologic recalls Sertera 14 Gauge Biopsy Devices due to potential needle detachment causing surgery delays. Affected devices have specific lot numbers and UDI-DI codes.
HologicMay 2, 2023 - Use cautionMedical device
Hologic, Inc. recalls Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC
Hologic recalls specific models of 3D medical C-Arms due to risk of unexpected movement causing blunt trauma. Affected units include RM-SDM-00001-3D and other models with serial numbers listed. Contact Hologic for details.
HologicJan 16, 2023 - Lower riskMedical device
Hologic, Inc recalls Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog
Hologic recalls sterilization trays and sizers due to missing instructions. Owners should check model numbers and lot dates to determine if affected. No immediate action needed but ensure proper use.
HologicOct 10, 2022 - Lower riskMedical device
Hologic, Inc recalls The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The
Hologic recalls BioZorb LP markers with expired labels that show incorrect dates. The product may be used incorrectly due to outdated expiration dates on removable labels.
HologicAug 9, 2022 - Lower riskMedical device
Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b
Hologic recalls Panther Fusion GBS Assay Cartridges (96 tests) due to potential false negative results when analyte concentrations are near detection limits. Affected lots include 274954, 284599, 296991, 300796, 309230, 309353.
HologicMar 18, 2022 - Lower riskMedical device
Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X
Hologic recalls Panther Fusion Extraction Reagent-X (lot 281375, 291829) due to potential false negative test results. Affected kits may not detect diseases correctly.
HologicJan 27, 2022 - Lower riskMedical device
Hologic, Inc recalls Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to
Hologic recalls 18-count Panther Fusion Tube Trays (PN: FA-15004) that may leak, causing false positive/negative test results. Affected units sold with specific lot numbers.
HologicFeb 26, 2021 - Lower riskMedical device
Hologic, Inc recalls Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Hologic recalls Panther Fusion Tube Tray (FAB-15004) due to potential leaks causing false negative results in flu, RSV, and paraflu assays. Affected units include specific box/tray lots listed in the recall notice.
HologicAug 4, 2020 - Use cautionMedical device
Hologic, Inc. recalls Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Hologic recalls Selenia Dimensions Mammography System model ASY-04160 with serial numbers 81002143175-81003143247 due to c-arm seizing or dropping during field repairs and cleaning, posing a risk of equipment damage or injury.
HologicJan 21, 2020 - Lower riskMedical device
Hologic, Inc recalls Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S,
Hologic recalls Panther Fusion Extraction Reagent-S (lot 258402) due to potential false positive/negative flu test results. Affected users should contact for remedy.
HologicOct 10, 2019 - Lower riskMedical device
Hologic, Inc. recalls I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Hologic recalls I-View Contrast Enhanced Digital Mammography units due to calibration issues affecting contrast visualization in subtracted images. All units are affected.
HologicDec 6, 2018 - Use cautionMedical device
Hologic, Inc recalls Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated
Hologic recalls Panther Fusion devices with serial numbers 2090002307-2492 due to risk of glass panel falling and hitting operators during use.
HologicJan 20, 2018 - UnratedMedical device
Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Hologic recalls Rapid cassettes (catalog 01200) due to unapproved material from a new supplier. This could pose risks if used without FDA approval. Affected users should check their model numbers.
HologicNov 29, 2017 - Lower riskMedical device
Hologic, Inc recalls Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hologic recalls Panther System (Catalog 902615) for potential incorrect test results due to an incorrect incubator installation. Affected units have serial number 20900001124.
HologicSep 15, 2017 - Lower riskMedical device
Hologic, Inc. recalls Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Hologic recalls Affirm Lateral Arm Upr: A component issue may affect needle alignment during breast biopsies. No injuries reported. Check product number ASY-09880 for affected units.
HologicJul 7, 2017 - Lower riskMedical device
Hologic, Inc recalls Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Hologic recalls Tomcat laboratory instruments with software anomaly that may cause incorrect patient results. Affected units include specific model numbers listed in the recall notice.
HologicJun 27, 2017
Hologic, Inc recall questions
How many recalls has Hologic, Inc had?
33 recalls from Hologic, Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Hologic, Inc recall?
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D,, dated Apr 8, 2026. Every Hologic, Inc recall is listed on this page, newest first.
What should I do if I have a recalled Hologic, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Hologic, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.