Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Cat... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036 | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | AXIOM Artis BA, Model Number 5904656 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog N... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Pr... | The firm has identified that cross-reactivity testing may not meet the claims indicated in the Ba... | Class II | Beckman Coulter Inc. |
| Jun 12, 2019 | AXIOM Artis dFC, Model Number 7727717 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis TA, Model Number 7007755 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catal... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | Artis zee multi, Model Number 10094139 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zeego, Model Number 10280959 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | Artis zee biplane, Model Number 10094141 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dTA, Model Number 7008605 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | Artis zee floor, Model Number 10094135 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | AXIOM Artis dFA, Model Number 7555373 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dBA, Model Number 7555357 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catal... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | Artis zee ceiling, Model Number 10094137 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO ... | There is a potential for the device to fail to deliver energy to the patient. | Class II | ZOLL Medical Corporation |
| Jun 12, 2019 | AXIOM Artis dBC, Model Number 7728392 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | AXIOM Artis dMP, Model Number 7555365 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | Artis zee floor MN, Model Number 10094142 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tu... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | AXIOM Artis FA, Model Number 5904441 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2019 | BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Cata... | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga... | Class II | Becton Dickinson & Company |
| Jun 12, 2019 | AXIOM Artis dTC, Model Number 7413078 | A tolerance issue in the power supply of the generator control above a specific value may cause g... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 11, 2019 | CTSTM Essential 8 Medium | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Jun 11, 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This pr... | The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate a... | Class II | Randox Laboratories, Limited |
| Jun 11, 2019 | StemPro¿ MSC SFM CTS" | Component was not tested by the supplier for adventitious agents | Class II | Life Technologies Corporation |
| Jun 10, 2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory in... | Lack of package integrity may compromise sterility | Class II | Santanello Surgical LLC |
| Jun 10, 2019 | Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Mo... | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounte... | Class II | Olympus Corporation of the Americas |
| Jun 10, 2019 | BrightView X , Model Number 882478 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | Luer Lock Set - Catalog # MPC-125, for IV administration sets. | Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrect... | Class II | Molded Products Inc |
| Jun 10, 2019 | Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only)... | Lack of an adequate sterilization validation. | Class II | Zimmer Biomet, Inc. |
| Jun 10, 2019 | BrightView SPECT, Model Number 882480 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat... | Class III | Randox Laboratories, Limited |
| Jun 10, 2019 | Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... | Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... | Class II | Abbott Gmbh & Co. KG |
| Jun 10, 2019 | Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only)... | Lack of an adequate sterilization validation. | Class II | Zimmer Biomet, Inc. |
| Jun 10, 2019 | BrightView XCT , Model Number 882482 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 7, 2019 | 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. | Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes du... | Class I | Centurion Medical Products Corporation |
| Jun 7, 2019 | Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RET... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVEST... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
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.