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Browse Device Recalls

42 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 42 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 42 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Dec 21, 2022 cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test ... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Dec 21, 2022 cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the... The firm received customer complaints regarding false negative Influenza A (Flu A) results and la... Class II Roche Molecular Systems, Inc.
Sep 8, 2022 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymeras... Reported false positive and invalid results on the affected devices due to anomalous baselines. T... Class II Roche Molecular Systems, Inc.
Nov 16, 2021 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material... Roche has identified a small number of cobas Liat analyzer units that have consistently high nois... Class II Roche Molecular Systems, Inc.
Sep 3, 2021 cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog N... False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas... Class II Roche Molecular Systems, Inc.
Aug 4, 2021 cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catal... Customers have reported an increased number of false positive SARS-CoV-2 results. Class II Roche Molecular Systems, Inc.
Mar 25, 2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coron... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Mar 25, 2021 cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catal... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Nov 23, 2020 uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871... When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t... Class II Roche Molecular Systems, Inc.
Nov 19, 2020 The cobas z 480 analyzer including dedicated software for IVD use is a plate-... Dirty Lens May Cause Invalid or False Positive Results Class II Roche Molecular Systems, Inc.
Jun 3, 2020 MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541... When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA P... Class II Roche Molecular Systems, Inc.
May 2, 2018 MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24... Cross-contamination of samples has been reported when running the existing protocol on the system... Class II Roche Molecular Systems, Inc.
Oct 27, 2017 Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes.... The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for... Class II Roche Molecular Systems, Inc.
Nov 16, 2016 LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time R... The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number 079... Class II Roche Molecular Systems, Inc.
May 17, 2016 cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... Kit labeled with the incorrect expiration date. Class III Roche Molecular Systems, Inc.
May 9, 2016 cobas¿ Liat¿ Analyzer Device was released with default pcal/gain settings for photometers instead of the pcal/gain set... Class II Roche Molecular Systems, Inc.
Apr 5, 2016 cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 ... During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 dele... Class II Roche Molecular Systems, Inc.
Mar 15, 2016 cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian ... An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instruct... Class II Roche Molecular Systems, Inc.
Mar 3, 2016 Hand-Held Scanner USB IT3800 For sample identification and tracking when use... The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identifie... Class II Roche Molecular Systems, Inc.
Jul 24, 2015 cobas Liat Analyzer, for in vitro diagnostic use. Due to a supplier issue, the incorrect green and amber LED components were used in the manufactur... Class II Roche Molecular Systems, Inc.
Jan 13, 2015 cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu... Class III Roche Molecular Systems, Inc.
Dec 18, 2014 cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten... cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C... Class III Roche Molecular Systems, Inc.
Jan 6, 2014 cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received ... Class II Roche Molecular Systems, Inc.
Jul 25, 2013 KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System... During an internal investigation, a formulation error that occurred was identified during the man... Class II Roche Molecular Systems, Inc.
Apr 1, 2013 cobas¿ 4800 system z480 instrument. Integrates fully automated total nu... In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.... Class II Roche Molecular Systems, Inc.
Nov 28, 2012 COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being u... Class II Roche Molecular Systems, Inc.
Oct 11, 2012 COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Auto... Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection... Class II Roche Molecular Systems, Inc.
Jul 31, 2012 cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecula... It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packag... Class III Roche Molecular Systems, Inc.
Jul 16, 2012 DataCara GM is an information management system that provides data management... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The COBAS 8000 data manager modular analyzer series (all versions) is a is a... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 Data Station AMPLILINK software is an instrument user interface/ data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 DataCare POC  is an information management system that provides data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Apr 23, 2012 Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK softw... Class II Roche Molecular Systems, Inc.
Feb 24, 2012 Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage... During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6... Class III Roche Molecular Systems, Inc.
Feb 1, 2012 COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. ... Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip)... Class II Roche Molecular Systems, 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.