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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.