Browse Device Recalls

93 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 93 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 93 FDA device recalls.

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DateProductReasonClassFirm
Jul 7, 2025 epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some e... Class II Siemens Healthcare Diagnostics Inc
Jun 26, 2025 RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot W... Class II Siemens Healthcare Diagnostics Inc
Mar 31, 2025 Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... Class II Siemens Healthcare Diagnostics Inc
Mar 19, 2025 epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ... The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... Class II Siemens Healthcare Diagnostics Inc
Mar 19, 2025 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M... The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... Class II Siemens Healthcare Diagnostics Inc
Sep 24, 2024 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lo... Class II Siemens Healthcare Diagnostics Inc
May 17, 2024 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended fo... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 26, 2023 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for ... RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodi... Class II Siemens Healthcare Diagnostics Inc
Oct 19, 2023 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... Class II Siemens Healthcare Diagnostics Inc
Sep 26, 2023 RAPIDPOINT 500e Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... Class II Siemens Healthcare Diagnostics Inc
Sep 26, 2023 RAPIDPOINT 500 Blood Gas System There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Aug 30, 2022 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Aug 30, 2022 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... Class II SIEMENS HEALTHCARE DIAGNOSTICS INC
Jun 1, 2022 epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of... Class II Siemens Healthcare Diagnostics Inc
Feb 9, 2022 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1... Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 3, 2021 Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: use... Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to disc... Class II Siemens Healthcare Diagnostics, Inc.
Aug 28, 2020 Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t... Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potentia... Class II Siemens Healthcare Diagnostics Inc
May 27, 2020 RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens M... The scanner is not confirming the integrity of read barcode data using the check-digit when readi... Class II Siemens Healthcare Diagnostics Inc
May 15, 2020 Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SM... Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... Class II Siemens Healthcare Diagnostics Inc.
May 15, 2020 Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #1... Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... Class II Siemens Healthcare Diagnostics Inc.
May 29, 2019 Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro ... Potential for increased rate of false positive results and/or increased rate of random non-repeat... Class II Siemens Healthcare Diagnostics Inc
Apr 10, 2017 RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... Potential Patient Demographic Error with Blank Patient ID Field Class II Siemens Healthcare Diagnostics Inc
Sep 2, 2016 Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... Class III Siemens Healthcare Diagnostics Inc
Sep 2, 2016 Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... Class III Siemens Healthcare Diagnostics Inc
Aug 11, 2016 Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Aug 11, 2016 Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... There is a potential for the first and/or last name of one patient to be printed with Patient ID ... Class II Siemens Healthcare Diagnostics Inc
Jul 5, 2016 Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... Class III Siemens Healthcare Diagnostics Inc
Jun 22, 2016 Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... Class II Siemens Healthcare Diagnostics Inc
May 11, 2016 Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 1044480... Premature bucket failures Class II Siemens Healthcare Diagnostics Inc.
Mar 24, 2016 Dimension Vista 1500 Intelligent Lab System running on software versions V.3.... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II Siemens Healthcare Diagnostics Inc.
Mar 24, 2016 Dimension Vista 500 Intelligent Lab System running on software versions V.3.6... Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... Class II Siemens Healthcare Diagnostics Inc.
Nov 11, 2015 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics 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.