Hologic, Inc recalls

12 recalls on record · latest: April 8, 2026

Official U.S. recall history for Hologic, Inc, compiled from official government records.

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Hologic, Inc recalls 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3…

April 8, 2026 · Medical device recalls Moderate risk Complaints have been received of systems developing loose, missing, or broken i…

Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6…

April 8, 2026 · Medical device recalls Moderate risk Complaints have been received of systems developing loose, missing, or broken i…

Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: C…

March 23, 2026 · Medical device recalls Moderate risk It was identified that certain devices were being operated outside the validate…

Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HP…

February 18, 2026 · Medical device recalls Moderate risk Due to product exhibiting potential to generate either invalid or false negativ…

Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

December 15, 2025 · Medical device recalls Moderate risk Presence of particulates in affected devices that can be deposited into breast…

Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

December 12, 2025 · Medical device recalls Moderate risk Fungal contamination of affected lot with Parengyodontium album.

Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version…

January 15, 2025 · Medical device recalls Moderate risk Devices presented a condition in which the inner needle separated from the hub…

Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 717…

January 8, 2025 · Medical device recalls Moderate risk Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) co…

Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

December 13, 2024 · Medical device recalls Moderate risk Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potent…

Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

November 8, 2024 · Medical device recalls Moderate risk SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false posit…

Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.

October 10, 2024 · Medical device recalls High risk Firm received reports of adverse events/complications that include serious inju…

Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s…

August 19, 2024 · Medical device recalls Moderate risk Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system…