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Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 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 39 FDA device recalls.

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DateProductReasonClassFirm
Apr 16, 2025 VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negati... Class II Luminex Corporation
Jun 20, 2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Potential for defective test cartridges which may result in false positive results for the Staphy... Class II Luminex Corporation
Nov 7, 2023 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul... Potentially defective utility trays in the reagent kits. Class II Luminex Corporation
Jun 5, 2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Jun 5, 2023 VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Sep 14, 2022 ARIES SARS-CoV-2 Assay, REF: 50-10047 A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction ... Class II Luminex Corporation
Jul 14, 2022 ARIES SARS-CoV-2 Assay SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A pos... Class II Luminex Corporation
Jun 17, 2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Jun 17, 2022 VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... Class II Luminex Corporation
Apr 5, 2022 Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Veri... Heater within the Verigene System may be outside of established temperature limits for assays wh... Class II Luminex Corporation
Feb 15, 2022 VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 Higher than normal "No Call Internal Control failures" due to a missing reagent within a small su... Class II Luminex Corporation
Nov 17, 2021 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking... Class II Luminex Corporation
Aug 3, 2021 Verigene EP Amplification Reagent Kit Test There is potential for false positive results. Class II Luminex Corporation
Apr 16, 2021 ARIES HSV 1&2 Assay, Part Number/REF 50-10017 Impacted lot may leak inside the ARIES instrument. Class II Luminex Corporation
Mar 18, 2021 VERIGENE Processor SP - Product Usage: intended for processing and identifyin... Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... Class II Luminex Corporation
Oct 30, 2020 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Num... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-0... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: ... Potential for a false-negative result. Class II Luminex Corporation
Oct 30, 2020 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:... Potential for a false-negative result. Class II Luminex Corporation
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field service engineers to s... Class II Luminex Corporation
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field service engineers to s... Class II Luminex Corporation
Jun 15, 2020 Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Cultu... An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... Class II Luminex Corporation
Jun 15, 2020 Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Cultur... An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... Class II Luminex Corporation
Apr 22, 2019 Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R Two of three complaints were initiated due to the customers repeatedly obtaining No Call results ... Class II Luminex Corporation
Feb 20, 2019 ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Feb 20, 2019 ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 Through internal investigation, it was discovered that a portion of side cassette assemblies (S... Class II Luminex Corporation
Dec 26, 2018 Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... Class III Luminex Corporation
Dec 10, 2018 VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device i... No results/incorrect results due to failure of the hybridization heater. Class II Luminex Corporation
Sep 14, 2018 VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac... Potential to lead to a false negative results. Class II Luminex Corporation
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... Class II Luminex Corporation
May 8, 2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... Class II Luminex Corporation
Apr 19, 2017 ARIES System and ARIES M1 System The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen i... Class II Luminex Corporation

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.