Hologic, Inc: 48 FDA recall reports
Every medical device recall the FDA has published for Hologic, Inc. The fault, and how the agency graded it.
48Reports
2Class I
23Ongoing
2026-05-20Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D,
Z-2167-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Product
- 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-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
- Where it went
- US Nationwide distribution.
- How much
- 4,305 units
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-
Z-2168-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Product
- 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.
- Where it went
- US Nationwide distribution.
- How much
- 14837 units
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalo
Z-1949-2026 · Class II · reported 2026-05-06 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
- How much
- 1200 units
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Descriptio
Z-1586-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- Due to product exhibiting potential to generate either invalid or false negative results.
- Product
- Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Where it went
- U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
- How much
- 306
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Z-1314-2026 · Class II · reported 2026-02-18 · Ongoing
- Why it was recalled
- Presence of particulates in affected devices that can be deposited into breast tissue during use.
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Where it went
- US Nationwide distribution.
- How much
- 681,870 units
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Z-1093-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Fungal contamination of affected lot with Parengyodontium album.
- Product
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Where it went
- US Nationwide distribution.
- How much
- 3,728 units
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Soft
Z-1170-2025 · Class II · reported 2025-02-19 · Ongoing
- Why it was recalled
- Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- Product
- 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
- Where it went
- Domestic: Nationwide Distribution
- How much
- 55,335 units
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit
Z-1095-2025 · Class II · reported 2025-02-12 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
- Where it went
- 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.
- How much
- 1351 units
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Z-0907-2025 · Class II · reported 2025-01-22 · Ongoing
- Why it was recalled
- Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
- Product
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Where it went
- AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
- How much
- 380
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Z-0694-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- Product
- Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
- Where it went
- US: AK
- How much
- 3
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/
Z-0669-2025 · Class II · reported 2024-12-18 · Completed
- Why it was recalled
- IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- Product
- Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
- Where it went
- US Nationwide distribution.
- How much
- 178 units
Class I
BioZorb Marker. Radiographic soft tissue marker.
Z-0328-2025 · Class I · reported 2024-12-04 · Ongoing
- Why it was recalled
- Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
- Product
- BioZorb Marker. Radiographic soft tissue marker.
- Where it went
- Domestic: US Nationwide Distribution.
- How much
- 12,710 units
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensio
Z-3248-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- 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
- Product
- 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 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)
- Where it went
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.
- How much
- 425 units
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Hori
Z-2373-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- 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.
- How much
- 2,642 units (1037 units US; 1605 units OUS)
Class I
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1)
Z-1733-2024 · Class I · reported 2024-05-15 · Ongoing
- Why it was recalled
- 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
- Product
- 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) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
- Where it went
- US Nationwide Distribution
- How much
- 53492
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent,
Z-1371-2024 · Class II · reported 2024-04-03 · Ongoing
- Why it was recalled
- Use of assay along with plasma specimen may result in error code which would invalidate sample.
- Product
- 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, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.
- Where it went
- 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.
- How much
- 684 kits
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system whic
Z-0782-2024 · Class II · reported 2024-01-31 · Ongoing
- Why it was recalled
- Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
- Product
- 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, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.
- Where it went
- 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.
- How much
- 771 systems (of which 313 are potentially impacted)
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors
Z-2035-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- Product
- 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 went
- US Nationwide distribution.
- How much
- 756 units
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3
Z-1144-2023 · Class II · reported 2023-03-01 · Ongoing
- Why it was recalled
- C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- Product
- 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-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
- Where it went
- US Nationwide distribution.
- How much
- 797 units
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue si
Z-1858-2022 · Class II · reported 2022-10-12 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
- Where it went
- 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.
- How much
- 233
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b
Z-0877-2022 · Class II · reported 2022-04-13 · Ongoing
- Why it was recalled
- Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
- Product
- Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
- Where it went
- US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
- How much
- 2061
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents
Z-0750-2022 · Class II · reported 2022-03-23 · Ongoing
- Why it was recalled
- Failed stability specifications for reagent kits that may result in false negative test results.
- Product
- 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
- Where it went
- 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.
- How much
- 264 kits
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consu
Z-1369-2021 · Class II · reported 2021-04-14 · Ongoing
- Why it was recalled
- There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
- Product
- 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.
- Where it went
- 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).
- How much
- 1355 kits
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Z-2990-2020 · Class II · reported 2020-09-30 · Terminated
- Why it was recalled
- 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.
- Product
- Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- Where it went
- 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
- How much
- 607
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagen
Z-2163-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- 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.
- Product
- 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), UDI: 15420045509214
- Where it went
- US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
- How much
- 47 kits
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Z-1343-2020 · Class II · reported 2020-03-04 · Terminated
- Why it was recalled
- 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.
- Product
- Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
- Where it went
- 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.
- How much
- 72
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Z-0685-2019 · Class II · reported 2019-01-02 · Terminated
- Why it was recalled
- Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
- Product
- I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- Where it went
- 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 South Africa Spain Switzerland Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
- How much
- 337 units
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Z-0676-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
- Where it went
- United States (US), Guam (GU), Japan (JP)
- How much
- 165 kits
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Z-0677-2018 · Class II · reported 2018-02-28 · Terminated
- Why it was recalled
- 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.
- Product
- Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
- Where it went
- United States (US), Guam (GU), Japan (JP)
- How much
- N/A
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully a
Z-0595-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
- Product
- 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 nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.
- Where it went
- Worldwide distribution
- How much
- 103 units
Showing the 30 most recent of 48. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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