Browse Device Recalls
571 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 571 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 571 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2019 | Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 3, 2019 | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Nu... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica Sample Handler Prime, Material Number 11069001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1600 Analyzer, Material Number 11066000 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 12, 2018 | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 12, 2018 | Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 7, 2018 | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 1049... | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 7, 2018 | Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 7, 2018 | Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 7, 2018 | SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 16, 2018 | Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 16, 2018 | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 11, 2018 | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vit... | Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) ma... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 28, 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model... | Thermal chamber motors have electrical cables with single insulation rather than the required dou... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... | 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 IM 1600 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 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 24, 2018 | ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vit... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vit... | A potential bias was identified with certain kits compared to the internal standards. | 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. |
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.