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
Jun 3, 2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... Class II Roche Diagnostics Corporation
Apr 4, 2019 cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 4, 2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Mar 18, 2019 Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit... The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due ... Class II Roche Diagnostics Corporation
Mar 15, 2019 cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCel... Class II Roche Diagnostics Corporation
Feb 4, 2019 Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential ... Class II Roche Diagnostics Corporation
Dec 17, 2018 Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 035... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 17, 2018 Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roc... Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 mo... Class II Roche Diagnostics Corporation
Dec 17, 2018 Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 17, 2018 Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***add... New endogenous interference claims have been established for the following assays used on the cob... Class II Roche Diagnostics Corporation
Dec 14, 2018 cobas c 111 with ISE analyzers analyzer used in the following assays: a)Crea... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and... Class II Roche Diagnostics Corporation
Dec 14, 2018 COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant A... COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and... Class II Roche Diagnostics Corporation
Sep 24, 2018 Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Pro... Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 u... Class II Roche Diagnostics Corporation
Sep 13, 2018 CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips... Abnormally high INR test results with the affected CoaguChek test strips Class I Roche Diagnostics Corporation
Jul 16, 2018 Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cob... Sample material may potentially come in contact with the pipetting nozzle during operation of cob... Class II Roche Diagnostics Corporation
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0702814819... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0746421516... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 3, 2018 cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... The syringe plunger on the device may be mounted in a tilted position, which applies mechanical s... Class II Roche Diagnostics Corporation
Feb 22, 2018 Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Feb 22, 2018 cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. Class II Roche Diagnostics Corporation
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... Class II Roche Diagnostics Corporation
Dec 22, 2017 Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination... Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to th... Class II Roche Diagnostics Corporation
Dec 18, 2017 Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometr... Complaints have been received concerning questionable results on analyzers due to customers utili... Class II Roche Diagnostics Corporation
Dec 18, 2017 cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical... Complaints have been received concerning questionable results on analyzers due to customers utili... Class II Roche Diagnostics Corporation
Dec 18, 2017 c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 mod... Complaints have been received concerning questionable results on analyzers due to customers utili... Class II Roche Diagnostics Corporation
Jul 28, 2017 Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... A software failure may incorrectly set the system settings to "default" settings, creating a risk... Class II Roche Diagnostics Corporation
Jul 18, 2017 cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 ... A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series ... Class II Roche Diagnostics Corporation
Jul 18, 2017 cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 ... A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODU... Class II Roche Diagnostics Corporation
Jul 5, 2017 Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jul 5, 2017 cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... Class II Roche Diagnostics Corporation
Jun 29, 2017 Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 17... Class II Roche Diagnostics Corporation
May 9, 2017 Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidire... a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the... Class II Roche Diagnostics Corporation
Apr 10, 2017 Elecsys PreciControl Varia 3 e-barcode and value sheet for PreciControl Varia contains a typographical error for the target va... Class II Roche Diagnostics Corporation
Mar 21, 2017 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular ... Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and l... Class II Roche Diagnostics Corporation
Mar 1, 2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... Class II Roche Diagnostics Corporation
Mar 1, 2017 Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... Class II Roche Diagnostics Corporation
Dec 27, 2016 cobas p 612 pre-analytical system; Pre-analytical sample handling that inc... Class II Roche Diagnostics 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.