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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 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 33 FDA device recalls.

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DateProductReasonClassFirm
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-10; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched... Class II Inpeco S.A.
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-40; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatche... Class II Inpeco S.A.
Sep 3, 2025 FlexLab (FLX) System. Potassium Test System. in vitro diagnostic The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis,... Class II Inpeco S.A.
Sep 3, 2025 FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysi... Class II Inpeco S.A.
Nov 3, 2023 Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automat... Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delay... Class II Inpeco S.A.
Mar 10, 2023 Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names ... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 PVT Interface Module (PVT)-Laboratory Automation system Brand names of the... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Mar 10, 2023 Storage and Retrieval Module (SRM)-Laboratory Automation system Brand name... Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or ... Class II Inpeco S.A.
Sep 10, 2021 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different br... The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to a... Class II Inpeco S.A.
Aug 7, 2020 FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... Class II Inpeco S.A.
Aug 7, 2020 Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual r... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... Class II Inpeco S.A.
Aug 7, 2020 Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual r... Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... Class II Inpeco S.A.
Jul 14, 2020 FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212... When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub... Class II Inpeco S.A.
Jul 14, 2020 Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) Th... When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub... Class II Inpeco S.A.
Jul 14, 2020 Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX... When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tub... Class II Inpeco S.A.
Apr 7, 2020 Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-2... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 7, 2020 Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System used with the following Modules: High Vol... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 FlexLab Automation System used with the following Modules: High Volume Storag... The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... Class II Inpeco S.A.
Apr 7, 2020 Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Apr 7, 2020 FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The... Potential for discrepant patient results due to a potential for the primary sample tube to be dil... Class II Inpeco S.A.
Apr 7, 2020 Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Pro... In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... Class II Inpeco S.A.
Apr 7, 2020 FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00,... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FL... In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... Class II Inpeco S.A.
Apr 7, 2020 Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N F... The identified problem is an erroneous association between the carrier and the sample tube caused... Class II Inpeco S.A.
Apr 7, 2020 Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers... When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... Class II Inpeco S.A.
Apr 7, 2020 Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA ... The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... Class II Inpeco S.A.
Aug 24, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product... The firm has identified customer sites where there are modules on which the safety pacemaker labe... Class II Inpeco S.A.
Feb 13, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Au... Module may freeze without generating user warning. There is a potential risk in delay of sample p... Class II Inpeco S.A.
Oct 4, 2016 FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed ... Inpeco received several notifications from the field about burnt schuko sockets. The customers re... Class II Inpeco S.A.

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.