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
Nov 11, 2015 Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... 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 CCRP 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
Nov 11, 2015 Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... 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" MYO TestPak-in vitro diagnostic test for the quantitative... 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 MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... 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 DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... 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 CKMB DilPak- 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" CCRP TestPak-in vitro diagnostic product intended to be u... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 10, 2015 Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Aug 24, 2015 Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number... RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... Class II Siemens Healthcare Diagnostics Inc
Jul 28, 2015 RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, ... When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one p... Class II Siemens Healthcare Diagnostics Inc
Jan 22, 2015 Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use wit... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Jan 22, 2015 Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use wi... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Jan 22, 2015 Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For us... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 103223... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 106968... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Jun 9, 2014 Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Sie... The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to altern... Class II Siemens Healthcare Diagnostics Inc.
May 23, 2014 RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurem... RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters ... Class II Siemens Healthcare Diagnostics Inc
May 22, 2014 Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ... RAPIDComm¿ 5.0 Screen Layout will display incorrect test names Class III Siemens Healthcare Diagnostics Inc
Mar 6, 2013 Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... Class II Siemens Healthcare Diagnostics, Inc.
Feb 26, 2013 CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemis... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N ... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class II Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M ... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Nov 21, 2012 Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry C... When these lots of control material are reconstituted, the positive control solution leukocyte re... Class III Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLa... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These sy... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLa... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPID... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoi... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These ... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... Class II Siemens Healthcare Diagnostics Inc
Sep 17, 2012 Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLa... RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... 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.