Browse Device Recalls

40 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 40 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 40 FDA device recalls.

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DateProductReasonClassFirm
Oct 22, 2025 BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of... Class II BioFire Diagnostics, LLC
Apr 30, 2025 BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Due to manufacturing error, respiratory panel may result in elevated control failures and/or fals... Class II BioFire Diagnostics, LLC
Feb 27, 2025 FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Increased risk of control failures and false negative test results with multiplexed nucleic acid ... Class II BioFire Diagnostics, LLC
Aug 7, 2024 FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2... Class II BioFire Diagnostics, LLC
Aug 7, 2024 FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2... Class II BioFire Diagnostics, LLC
Jun 19, 2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for... If blood culture identification panel is used in conjunction with specific lots of culture media ... Class II BioFire Diagnostics, LLC
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
May 16, 2024 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit... Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport m... Class II BioFire Diagnostics, LLC
Jan 26, 2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD B... Due to a trend in false positive Candida tropicalis results on blood culture panel when using cer... Class II BioFire Diagnostics, LLC
Jan 26, 2024 FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-... Due to potential signals of increased false positive Norovirus results when using the gastrointes... Class II BioFire Diagnostics, LLC
Dec 14, 2023 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only... Their is a potential for false positive results when using Pneumonia panel. Class II BioFire Diagnostics, LLC
Dec 14, 2023 FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IV... Their is a potential for false positive results when using Pneumonia panel. Class II BioFire Diagnostics, LLC
Nov 27, 2023 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nu... A manufacturing event may contribute to elevated rates of false negative results while using gast... Class II BioFire Diagnostics, LLC
Nov 27, 2023 The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic ... A manufacturing event may contribute to elevated rates of false negative results while using gast... Class II BioFire Diagnostics, LLC
Oct 17, 2023 FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base w... Due to an increased risk of degradation of the power entry switch resulting from arcing inside of... Class II BioFire Diagnostics, LLC
Oct 17, 2023 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, use... Routine quality control testing of affected blood culture identification panel with affected cont... Class II BioFire Diagnostics, LLC
May 8, 2023 FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems... Due to manufacturing issue, panels may result in false negative results. Class II BioFire Diagnostics, LLC
May 8, 2023 BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IV... Due to manufacturing issue, panels may result in false negative results. Class II BioFire Diagnostics, LLC
Apr 25, 2023 FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011... The firm has identified an increased risk of obtaining false positive Cryptosporidium results fro... Class II BioFire Diagnostics, LLC
Mar 8, 2023 FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-01... Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. Class II BioFire Diagnostics, LLC
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 Due to temperature excursions with products (products being stored outside of the required temper... Class II BioFire Diagnostics, LLC
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - RE... Due to temperature excursions with products (products being stored outside of the required temper... Class II BioFire Diagnostics, LLC
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 Due to temperature excursions with products (products being stored outside of the required temper... Class II BioFire Diagnostics, LLC
Oct 11, 2021 BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 U... Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results... Class II BioFire Diagnostics, LLC
Jul 20, 2021 FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: ... Due to product complaints received for false negative results (dropouts) with blood culture ident... Class II BioFire Diagnostics, LLC
Jun 7, 2021 FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-A... Due to real-time stability study failures resulting in increase rate of false negative results be... Class II BioFire Diagnostics, LLC
Jun 7, 2021 FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 /... Due to real-time stability study failures resulting in increase rate of false negative results be... Class II BioFire Diagnostics, LLC
May 10, 2021 BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Cult... Elevated rates of false negative results may occur when using blood culture panels due to issues ... Class II BioFire Diagnostics, LLC
Apr 16, 2021 FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Elevated rates of false positive/false negative and control failures while using the Pneumonia Pa... Class II BioFire Diagnostics, LLC
Jan 26, 2021 BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 0081538102033... The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID... Class II BioFire Diagnostics, LLC
Jan 26, 2021 Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood C... The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID... Class II BioFire Diagnostics, LLC
Jan 22, 2020 FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 008153810200... There is an increased risk of false positive Proteus results when using the Film Array Blood Cult... Class II BioFire Diagnostics, LLC
Jan 22, 2020 FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020... There is an increased risk of false positive Proteus results when using the Film Array Blood Cult... Class II BioFire Diagnostics, LLC
Aug 8, 2019 FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (... Complaints have been received concerning elevated rates of false negative results while using the... Class II BioFire Diagnostics, LLC
Mar 7, 2019 FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126,... Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected bloo... Class II BioFire Diagnostics, LLC
Mar 6, 2019 FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC... Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. Class II BioFire Diagnostics, LLC
Sep 10, 2018 -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) ... Firm identified an issue in the manufacturing process which might contribute to elevated rates of... Class II BioFire Diagnostics, LLC
Sep 5, 2018 FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnos... Increased risk of false positive results for Proteus when the product is used with a specific blo... Class II BioFire Diagnostics, LLC
Mar 14, 2018 FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RF... There is an increased risk of false positive Proteus results when the product is used with specif... Class II BioFire Diagnostics, LLC

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.