Browse Device Recalls
454 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 454 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 454 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2018 | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens.... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 7, 2018 | Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usa... | There is lot to lot variability for QC and patient results when using the identified reagent cart... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 7, 2018 | Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Produ... | There is lot to lot variability for QC and patient results when using the identified reagent cart... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO CENTRIFUGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 9000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO RACK OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 15000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 9000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO INPUT/OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB CORE UNIT / LYNX WITH IOM | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO RACK INPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 15000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 16, 2018 | RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10... | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 16, 2018 | RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 ... | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 16, 2018 | RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is ... | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 16, 2018 | RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is... | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 19, 2018 | Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 19, 2018 | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immu... | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 27, 2018 | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2018 | Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205 | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2018 | Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971 | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 21, 2018 | Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586 | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic t... | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing... | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 30, 2018 | Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023,... | May produce erroneously low results from specific well sets. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ Folate (FOL) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 TG | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ Cyclosporine | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 CEA | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ HBc IgM | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | 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.