Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2021 | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite... | Due to calibration curves producing a higher activity than routinely expected and that there may ... | Class II | The Binding Site Group, Ltd. |
| Oct 15, 2021 | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 | XXX | Class II | Howmedica Osteonics Corp. |
| Oct 15, 2021 | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual ... | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 15, 2021 | Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET... | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... | Class II | Medtronic Vascular, Inc. |
| Oct 15, 2021 | 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 | There is a potential for the outer white Tyvek lid to debond from the sealed package. | Class II | Howmedica Osteonics Corp. |
| Oct 15, 2021 | Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual ... | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 14, 2021 | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... | Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... | Class III | Cardiac Assist, Inc |
| Oct 14, 2021 | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of inte... | Endotoxin levels exceeded allowable limits. | Class II | Beeken Biomedical, LLC |
| Oct 14, 2021 | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Lumenis, Inc. |
| Oct 14, 2021 | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | While cleaning or disinfecting the system, if the process is not followed as described in the man... | Class II | SEDECAL SA |
| Oct 14, 2021 | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Nu... | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become... | Class II | Hill-Rom Inc. |
| Oct 14, 2021 | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only ... | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | Class II | BioCheck, Inc. |
| Oct 13, 2021 | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. R... | Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior... | Class II | Cook Inc. |
| Oct 13, 2021 | Oncentra Brachy users using version 4.0 and above with Applicator Modeling li... | Under certain circumstances, there can be a difference between the planned and delivered dose of ... | Class II | Elekta, Inc. |
| Oct 13, 2021 | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic... | The firm has received customer reports of performance issues with the affected lot, including inc... | Class II | Instrumentation Laboratory |
| Oct 12, 2021 | Medtronic CareLink SmartSync Device Manager application software (D00U005) us... | The processing of collected episode data may fail due to a software error. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 12, 2021 | Artis icono floor with software VE20C-diagnostic imaging angiography system ... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2021 | Artis icono biplane with software VE20C-diagnostic imaging angiography system... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2021 | Artis pheno with software VE20C- diagnostic imaging angiography system Mode... | Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and ... | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | Class II | Medtronic Perfusion Systems |
| Oct 11, 2021 | BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 U... | Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results... | Class II | BioFire Diagnostics, LLC |
| Oct 11, 2021 | Affected components are limited to the Monoprice charging cable (Product # 48... | Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause ... | Class II | Forbes Rehab Services Inc |
| Oct 11, 2021 | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual... | Class II | Jjgc Industria E Comercio De Materials Dentario... |
| Oct 11, 2021 | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive... | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay | Class II | Clark Laboratories, Inc. |
| Oct 8, 2021 | bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cat... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Civco Medical Instruments Co. Inc. |
| Oct 8, 2021 | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G0236... | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not... | Class II | Cook Inc. |
| Oct 8, 2021 | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Civco Medical Instruments Co. Inc. |
| Oct 8, 2021 | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xsta... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Civco Medical Instruments Co. Inc. |
| Oct 8, 2021 | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or c... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surg... | Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain beve... | Class II | Beaver Visitec International, Inc. |
| Oct 8, 2021 | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Co... | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not... | Class II | Cook Inc. |
| Oct 8, 2021 | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Civco Medical Instruments Co. Inc. |
| Oct 7, 2021 | BioGlue Surgical Adhesive, Model BG3510-5-G | Product is not approved for use in the EU and should not have been distributed in the EU. | Class II | CryoLife, Inc. |
| Oct 7, 2021 | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 | Mislabeled product. | Class II | SCIENCE & BIO MATERIALS |
| Oct 6, 2021 | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catal... | Potential for breakage of the ECG electrode carbon stud from the eyelet. | Class II | 3M Company - Health Care Business |
| Oct 6, 2021 | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens C... | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cas... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 5, 2021 | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... | The Control Level I material value was showing results exceeding the upper limit of the acceptabl... | Class III | Primus Corporation dba Trinity Biotech |
| Oct 5, 2021 | Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10... | System operator manual states that the system should be rebooted once, every 7 days. In some case... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 5, 2021 | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Con... | The Control Level I material value was showing results exceeding the upper limit of the acceptabl... | Class III | Primus Corporation dba Trinity Biotech |
| Oct 4, 2021 | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE... | Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. | Class II | Argon Medical Devices, Inc |
| Oct 4, 2021 | Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... | The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui... | Class II | AB SCIEX |
| Oct 4, 2021 | THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA | Product was released prior to all testing being completed. If used and a drive tube leak were to ... | Class II | Therakos, Inc. |
| Oct 1, 2021 | SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Oct 1, 2021 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
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.