Browse Device Recalls
580 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 580 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 580 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2019 | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100... | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitig... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 30, 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in s... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red b... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 15, 2019 | Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage:... | Negative Bias with Lot EA9227. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2K... | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2019 | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | There is a potential for low discordant progesterone results on a subset of patient samples. A f... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 27, 2019 | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de... | Iincreased (falsely elevated) Albumin results compared to expected results | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
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.