Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

Clear
DateProductReasonClassFirm
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.
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.
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.
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.
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.
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.
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.
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.
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.