Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0290-2022 | Class II | Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE... | Medtronic, Inc. | MIH | |
| Z-0274-2022 | Class II | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human... | The Binding Site Group Ltd. | DEH | |
| Z-0247-2022 | Class III | VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in... | Ortho-Clinical Diagnostics, Inc. | JJX | |
| Z-1083-2024 | Class II | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | Sedecal S.A. | IZL | |
| Z-0311-2022 | Class III | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary... | Cardiac Assist, Inc | DWF | |
| Z-0309-2022 | Class II | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ... | Beeken Biomedical LLC | POD | |
| Z-0402-2022 | Class II | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6... | Hill-Rom Inc. | ILQ | |
| Z-0214-2022 | Class II | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This... | BioCheck Inc | KLI | |
| Z-0194-2022 | Class I | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L... | Lumenis Ltd | ITX | |
| Z-0192-2022 | Class II | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-0191-2022 | Class II | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-0190-2022 | Class II | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-0189-2022 | Class II | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-0414-2022 | Class II | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle... | Cook Incorporated | LJE | |
| Z-0276-2022 | Class II | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic... | Instrumentation Laboratory Co. | GJS | |
| Z-0182-2022 | Class II | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license... | Elekta Limited | MUJ | |
| Z-0517-2022 | Class II | Artis icono floor with software VE20C-diagnostic imaging angiography system Model... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0516-2022 | Class II | Artis icono biplane with software VE20C-diagnostic imaging angiography system Model... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0515-2022 | Class II | Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0491-2022 | Class II | Medtronic Custom Perfusion kits, with the following product descriptions and... | Medtronic Perfusion Systems | DWF | |
| Z-0282-2022 | Class II | Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the... | Medtronic, Inc. | OSR | |
| Z-0423-2022 | Class II | Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W... | Forbes Rehab Services Inc | ILQ | |
| Z-0382-2022 | Class II | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis... | Trinity Biotech USA | MJH | |
| Z-0312-2022 | Class II | BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI... | BioFire Diagnostics, LLC | PEN | |
| Z-0203-2022 | Class II | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | |
| Z-0398-2022 | Class II | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-0397-2022 | Class II | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-0396-2022 | Class II | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-0395-2022 | Class II | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX | CIVCO Medical Instruments Co., Inc. | IYO | |
| Z-0230-2022 | Class II | bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent... | Becton Dickinson & Co | OJK | |
| Z-0229-2022 | Class II | bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits... | Becton Dickinson & Co | OJK | |
| Z-0228-2022 | Class II | bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract... | Becton Dickinson & Co | OJK | |
| Z-0227-2022 | Class II | Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract... | Becton Dickinson & Co | HNN | |
| Z-0223-2022 | Class II | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set... | Cook Incorporated | N/A | |
| Z-0222-2022 | Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product... | Cook Incorporated | DRC | |
| Z-1361-2022 | Class II | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 | Science & Bio Materials, S.B.M. SAS | HWC | |
| Z-0384-2022 | Class II | BioGlue Surgical Adhesive, Model BG3510-5-G | Artivion, Inc. | MUQ | |
| Z-0193-2022 | Class II | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-0188-2022 | Class II | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244... | 3M Company | DRX | |
| Z-0350-2023 | Class III | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part... | Trinity Biotech (Primus Corporation dba Trinity Biotech) | JPK | |
| Z-0349-2023 | Class III | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for... | Trinity Biotech (Primus Corporation dba Trinity Biotech) | JPK | |
| Z-0226-2022 | Class II | Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2)... | Siemens Medical Solutions USA, Inc. | MUQ | |
| Z-0212-2022 | Class II | THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA | Therakos Inc | LNR | |
| Z-0354-2022 | Class II | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY... | Argon Medical Devices, Inc | KNW | |
| Z-0175-2022 | Class II | Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX... | AB Sciex, LLC | DOP | |
| Z-0237-2022 | Class II | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended... | Omni Life Science, Inc. | LPH | |
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for... | Cordis US Corp. | FGE | |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for... | Cordis US Corp. | FGE | |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use... | Cordis US Corp. | FGE | |
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T. Flex Biliary Stent System is indicated for... | Cordis US Corp. | FGE |