Browse Device Recalls
43 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 43 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 43 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 18, 2026 | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog N... | Due to product exhibiting potential to generate either invalid or false negative results. | Class II | Hologic, Inc. |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
| Dec 12, 2025 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Hologic, Inc |
| Jan 15, 2025 | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model... | Devices presented a condition in which the inner needle separated from the hub and produced a lon... | Class II | Hologic, Inc |
| Jan 8, 2025 | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... | Class II | Hologic, Inc. |
| Dec 13, 2024 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reag... | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or... | Class II | Hologic, Inc. |
| Nov 8, 2024 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. | Class II | Hologic, Inc. |
| Oct 10, 2024 | BioZorb Marker. Radiographic soft tissue marker. | Firm received reports of adverse events/complications that include serious injuries, such as pain... | Class I | Hologic, Inc |
| Mar 13, 2024 | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... | Safety Information: Complaints describe complications/adverse events that include pain, infection... | Class I | Hologic, Inc |
| Dec 15, 2023 | PANTHER FUSION System REF 9121010000 The Panther System is an integrated... | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. | Class II | Hologic, Inc. |
| Sep 14, 2023 | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW... | Use of assay along with plasma specimen may result in error code which would invalidate sample. | Class II | Hologic, Inc. |
| May 2, 2023 | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy sa... | The inner needle of the Sertera device is either detaching or discharging and may cause delay in ... | Class II | Hologic, Inc |
| Jan 16, 2023 | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-... | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual | Class II | Hologic, Inc. |
| Oct 10, 2022 | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ... | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions f... | Class II | Hologic, Inc |
| Aug 9, 2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate ... | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels ... | Class II | Hologic, Inc |
| Mar 18, 2022 | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in ... | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of de... | Class II | Hologic, Inc |
| Jan 27, 2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusi... | Failed stability specifications for reagent kits that may result in false negative test results. | Class II | Hologic, Inc |
| Feb 26, 2021 | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - ... | There is a potential for tube trays to leak which could potentially result in false positive res... | Class II | Hologic, Inc |
| Aug 4, 2020 | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | Tube trays may leak which could invalidate patient results or assay worklists, causing delayed re... | Class II | Hologic, Inc |
| Jan 21, 2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimens... | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions sys... | Class II | Hologic, Inc. |
| Oct 10, 2019 | Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisti... | Reagent component included in flu test kit may cause both high background signal in a true negati... | Class II | Hologic, Inc |
| Dec 6, 2018 | I-View¿ Contrast Enhanced Digital Mammography, ASY-08109 | Calibration issue not possible to visualize contrast uptake in the subtracted mammography images | Class II | Hologic, Inc. |
| Jan 20, 2018 | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: Th... | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and... | Class II | Hologic, Inc |
| Nov 29, 2017 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... | Class II | Hologic, Inc. |
| Nov 29, 2017 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... | Class II | Hologic, Inc. |
| Sep 15, 2017 | Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In... | An incorrect incubator was installed on one Panther System which potentially led to incorrect Apt... | Class II | Hologic, Inc |
| Jul 7, 2017 | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 | The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Ac... | Class II | Hologic, Inc. |
| Jun 27, 2017 | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... | Class II | Hologic, Inc |
| Oct 28, 2016 | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ... | Breach in sterile barrier compromising product sterility | Class II | Hologic, Inc |
| Aug 22, 2016 | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast bi... | Incorrect label on the Sertera Biopsy Kit | Class II | Hologic, Inc |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| May 31, 2016 | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister u... | Cracks ATEC Canister Lids. | Class II | Hologic, Inc |
| Mar 31, 2016 | CF InPlex ASR Card; Catalog Number: 95-0501. | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... | Class II | Hologic, Inc |
| Mar 31, 2016 | Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. | Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... | Class II | Hologic, Inc |
| May 13, 2014 | Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, ... | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t... | Class II | Hologic, Inc. |
| May 13, 2014 | Hologic M-IV Mammography System; Model M4--00001. Intended to produce radi... | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use t... | Class II | Hologic, Inc. |
| Jan 24, 2014 | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Cont... | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC ... | Class II | Hologic, Inc |
| Sep 6, 2013 | Selenia Full Field Digital Mammography System with software versions 5.0.x an... | Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4... | InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ... | Class II | Hologic, Inc. |
| Sep 14, 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an... | Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b... | Class II | Hologic, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.