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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Jun 19, 2020 Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... Quality Control results were not properly evaluated for QC failures. Class II Abbott Gmbh & Co. KG
May 12, 2020 Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. There is a potential to generate incorrect patient results for the following assays: Alkaline Pho... Class II Abbott Gmbh & Co. KG
Apr 24, 2020 ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ... Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High... Class II Abbott Gmbh & Co. KG
Mar 9, 2020 ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading t... Class II Abbott Gmbh & Co. KG
Jan 24, 2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... Class II Abbott Gmbh & Co. KG
Nov 7, 2019 ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Rel... Class II Abbott Gmbh & Co. KG
Oct 23, 2019 Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnos... Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed int... Class II Abbott GmBH & Co. KG
Sep 16, 2019 Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Sep 16, 2019 Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Sep 16, 2019 Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Jun 10, 2019 Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... Class II Abbott Gmbh & Co. KG
May 21, 2019 The Alinity ci-series System Control Modules which are configured with Alinit... All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... Class II Abbott Gmbh & Co. KG
Apr 15, 2019 Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity... Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designe... Class II Abbott Gmbh & Co. KG
Apr 5, 2019 Alinity i Processing Module, 03R65 01, with the below components. a. TED (... Potential loose cable connections on the reagent cooler, which could result in temperature errors... Class II Abbott Gmbh & Co. KG
Mar 7, 2019 Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7... Potential performance issues in the Alinity-ci software version 2.5.1 Class II Abbott Gmbh & Co. KG
Feb 26, 2019 Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i... The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... Class II Abbott Gmbh & Co. KG
Feb 26, 2019 Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c... The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... Class II Abbott Gmbh & Co. KG
Dec 20, 2018 Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30... Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) ... Class II Abbott Gmbh & Co. KG
Dec 14, 2017 ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar... Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from ... Class II Abbott Gmbh & Co. KG

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.