Hologic Recalls
48 recalls on record · October 3, 2012 to May 20, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 24, 2018Medical DevicesFDA
Hologic, Inc. recalls Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Hazard: 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.
October 25, 2017Medical DevicesFDA
Hologic, Inc recalls Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hazard: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
August 9, 2017Medical DevicesFDA
Hologic, Inc recalls Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Hazard: A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
November 30, 2016Medical DevicesFDA
Hologic, Inc recalls SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) c
Hazard: Breach in sterile barrier compromising product sterility
September 28, 2016Medical DevicesFDA
Hologic, Inc recalls Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Hazard: Incorrect label on the Sertera Biopsy Kit
September 14, 2016Medical DevicesFDA
Hologic, Inc recalls SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization S
Hazard: Tip Breakage at the glue joint between the obturator body and tip
September 14, 2016Medical DevicesFDA
Hologic, Inc recalls SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization S
Hazard: Tip Breakage at the glue joint between the obturator body and tip
July 27, 2016Medical DevicesFDA
Hologic, Inc recalls ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy
Hazard: Cracks ATEC Canister Lids.
May 4, 2016Medical DevicesFDA
Hologic, Inc recalls Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Hazard: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
May 4, 2016Medical DevicesFDA
Hologic, Inc recalls CF InPlex ASR Card; Catalog Number: 95-0501.
Hazard: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
June 11, 2014Medical DevicesFDA
Hologic, Inc. recalls Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screenin
Hazard: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
June 11, 2014Medical DevicesFDA
Hologic, Inc. recalls Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full F
Hazard: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
March 5, 2014Medical DevicesFDA
Hologic, Inc recalls NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Nu
Hazard: NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
October 9, 2013Medical DevicesFDA
Hologic, Inc. recalls Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital M
Hazard: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
May 22, 2013Medical DevicesFDA
Hologic, Inc. recalls Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imagi
Hazard: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
May 22, 2013Medical DevicesFDA
Hologic, Inc. recalls Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System
Hazard: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
October 3, 2012Medical DevicesFDA
Hologic, Inc. recalls Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluor
Hazard: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.
October 3, 2012Medical DevicesFDA
Hologic, Inc. recalls Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoros
Hazard: InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.