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-1913-2009 | Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use... | Edwards Lifesciences LLC | DYB | ||
| Z-1872-2009 | ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico... | Acist Medical Systems, Inc. | DXT | ||
| Z-0083-2012 | Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a... | Data Innovations, LLC | JQP | ||
| Z-2052-2009 | Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number... | Boston Scientific Corporation | NJE | ||
| Z-1809-2009 | Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number... | Varian Medical Systems, Inc. | IYE | ||
| Z-1672-2009 | 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-1671-2009 | 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-1914-2009 | Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a... | Abiomed, Inc. | DSQ | ||
| Z-1674-2009 | Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B... | Essential Medical Supply, Inc. | ITJ | ||
| Z-1420-2012 | Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three... | Baxter Corporation Englewood | LHI | ||
| Z-1558-2009 | Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5... | GE Healthcare | MSX | ||
| Z-1418-2009 | Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table... | STRYKER Communications, Inc. | FQO | ||
| Z-0598-2012 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product... | Baxter Healthcare Corporation | FRN | ||
| Z-2212-2011 | AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate The AutoMate... | Siemens Healthcare Diagnostics Inc. | LXG | ||
| Z-2771-2011 | UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC... | Siemens Healthcare Diagnostics Inc. | LIG | ||
| Z-0366-2010 | AGFA IMPAX HeartStation ECG Management System. | AGFA Healthcare Corp. | LLZ | ||
| Z-1812-2009 | Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog... | Remel Inc | LIO | ||
| Z-1686-2009 | DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm... | Depuy Orthopaedics Inc. | JWH | ||
| Z-1567-2009 | Smith & Nephew Endoscopic Disposable Blades:TURBOWHISKER BLD,EP-1,4.5MM(6) Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1566-2009 | Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1 Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1565-2009 | Smith & Nephew Endoscopic Disposable Blades: BOXED F/R,BL,4.5MM,SERIES 3000 /6 Product... | Smith & Nephew, Inc. | NBH | ||
| Z-1564-2009 | Smith & Nephew Endoscopic Disposable Blades: DISPOSABLE BL,4.5MM FR ELITE Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1563-2009 | Smith & Nephew Endoscopic Disposable Blades: INCISOR, 5.5mm,EP-1,DSPL BLADE Product #... | Smith & Nephew, Inc. | NBH | ||
| Z-1562-2009 | Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1561-2009 | Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1560-2009 | Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER 3000 Part #... | Smith & Nephew, Inc. | NBH | ||
| Z-1178-2010 | Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number... | Abbott Vascular | LIT | ||
| Z-1733-2009 | Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the... | Remel Inc | JSY | ||
| Z-1871-2009 | Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals... | Whatman, Inc. | JKA | ||
| Z-1734-2009 | CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater... | Veridex, LLC | GKH | ||
| Z-1657-2009 | Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of... | Abbott Vascular | MGB | ||
| Z-0371-2010 | Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint... | Globus Medical, Inc. | HSX | ||
| Z-1632-2009 | Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, latex free, sterile, Boston... | Boston Scientific Corporation | KNT | ||
| Z-1631-2009 | Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile... | Boston Scientific Corporation | KNT | ||
| Z-1630-2009 | Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free... | Boston Scientific Corporation | KNT | ||
| Z-1629-2009 | Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with... | Boston Scientific Corporation | KNT | ||
| Z-1628-2009 | Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with... | Boston Scientific Corporation | KNT | ||
| Z-1627-2009 | Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free... | Boston Scientific Corporation | KNT | ||
| Z-1626-2009 | Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile... | Boston Scientific Corporation | KNT | ||
| Z-1625-2009 | Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile... | Boston Scientific Corporation | KNT | ||
| Z-1732-2009 | Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45... | Accriva Diagnostics, Inc. | JBP | ||
| Z-1436-2009 | CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection... | Philips North America LLC | DXJ | ||
| Z-1654-2009 | Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data... | Philips North America LLC | DXJ | ||
| Z-1720-2009 | GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image... | GE Healthcare | JAK | ||
| Z-2207-2010 | Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as... | Monarch Labs, LLC | NQK | ||
| Z-0007-2011 | HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and... | GE Healthcare | JAK | ||
| Z-1170-2010 | LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional... | Lockheed-Martin Aculight | RDW | ||
| Z-0973-2010 | "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on... | Kamiya Biomedical Company, LLC | DCK | ||
| Z-1658-2009 | Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray... | NRT X-Ray a/S | JAA | ||
| Z-0469-2011 | The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva... | Philips North America LLC | LNH |