Manufacturer
48 recalls in our database name Hologic, Inc. as the manufacturing or recalling firm.
Of the 48 recalls from Hologic, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (8%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.
Hologic is recalling 337 I-View Contrast Enhanced Digital Mammography systems due to a calibration issue that prevents visualization of contrast uptake.
Hologic is recalling Rapid for the TLiIQ System cassettes because they were manufactured with material from a new supplier before FDA approval of the change.
Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.
Hologic is recalling 103 Panther Fusion instruments because the glass panel may separate from the monitor and fall, potentially striking an operator.
Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.
Hologic is recalling one Panther System unit in Indiana because an incorrect incubator was installed, which may have led to incorrect Aptima Combo 2 assay results.
Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.
Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.
Hologic is recalling 570 units of the Sertera Biopsy Device due to incorrect labeling on the sterile kit.
Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.
Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.
Hologic is recalling 16,870 ATEC Suction Canisters because the lids may crack. These devices are used to collect fluid during breast biopsies.
Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.
Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.
Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.
Hologic is recalling 93 NovaSure Radiofrequency Controllers because they may not meet the IEC 60601-1 electrical safety standard.
Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.
Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.
Hologic is recalling Fluoroscan Mini C-arm InSight2 systems because the audible alarm and total cumulative irradiation time displays are inaccurate.
Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.
Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Hologic
medical technology company
Source: Wikidata (Q5884072), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.