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-1758-2015 | Class II | Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5... | Edwards Lifesciences LLC | DXC | |
| Z-0168-2016 | Class II | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1700-2015 | Class II | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed... | Edwards Lifesciences LLC | DYG | |
| Z-1750-2015 | Class II | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | ResMed Corp | CBK | |
| Z-1960-2015 | Class II | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink... | Spine Wave Inc | ETN | |
| Z-1810-2015 | Class II | Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and... | Stryker Corp. | HAW | |
| Z-1606-2015 | Class II | GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). | GE Healthcare | MHX | |
| Z-1748-2015 | Class II | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack... | Remel Inc | JSG | |
| Z-1730-2015 | Class II | Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH... | Abbott Medical | FPA | |
| Z-1650-2016 | Class II | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-1637-2015 | Class I | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | DXZ | |
| Z-2461-2015 | Class II | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for... | Ferno-Washington Inc | FPO | |
| Z-1806-2015 | Class II | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part... | Becton Dickinson & Co | FSY | |
| Z-1805-2015 | Class II | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part... | Becton Dickinson & Co | FSY | |
| Z-1804-2015 | Class II | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part... | Becton Dickinson & Co | FSY | |
| Z-1803-2015 | Class II | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part... | Becton Dickinson & Co | FSY | |
| Z-1688-2015 | Class II | Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-1802-2015 | Class II | BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part... | Becton Dickinson & Co | FSY | |
| Z-1741-2015 | Class II | Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for... | Zimmer GmbH | KTT | |
| Z-2056-2015 | Class II | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic... | Integra Pain Management | BSP | |
| Z-1687-2015 | Class II | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion... | Terumo Cardiovascular Systems Corporation | DTQ | |
| Z-1795-2015 | Class II | I-Portal NOTC and VNG; a device used to measure, record, or visually display the... | Spryson America Inc | GWN | |
| Z-1822-2015 | Class II | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal... | Smith & Nephew, Inc. | GAT | |
| Z-1696-2015 | Class II | PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical... | Zimmer GmbH | LXH | |
| Z-2250-2016 | Class II | Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE... | Centurion Medical Products, LP | FSY | |
| Z-1919-2015 | Class II | LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For... | Diametrics Medical, Inc. | CHL | |
| Z-1694-2015 | Class II | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System... | Zimmer GmbH | NDJ | |
| Z-1726-2015 | Class I | HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102... | HeartWare, Inc. | DSQ | |
| Z-1751-2015 | Class II | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation... | HeartWare, Inc. | DSQ | |
| Z-1917-2015 | Class II | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation... | HeartWare, Inc. | DSQ | |
| Z-1731-2015 | Class I | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS... | HeartWare, Inc. | DSQ | |
| Z-1942-2015 | Class II | EasyLink Data Management System; a clinical data management system that assists medical... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-1640-2015 | Class II | Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx... | Richard-Allan Scientific LLC | LEA | |
| Z-1639-2015 | Class II | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying... | Richard-Allan Scientific LLC | LEA | |
| Z-1698-2015 | Class I | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100... | HeartWare, Inc. | DSQ | |
| Z-1604-2015 | Class I | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is... | HeartWare, Inc. | DSQ | |
| Z-1740-2015 | Class III | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus... | Acclarent Inc | KAM | |
| Z-1702-2015 | Class II | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical... | Alcon Laboratories | LRO | |
| Z-1599-2015 | Class II | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use. | Medtronic, Inc. | PJQ | |
| Z-1837-2015 | Class II | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY... | DeRoyal Industries, Inc. | LRO | |
| Z-1709-2015 | Class II | 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only... | Aquabiliti | NGT | |
| Z-1941-2015 | Class II | Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter... | Boston Scientific Corporation | FGE | |
| Z-1953-2015 | Class II | Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant. | Sheffield Pharmaceuticals LLC | MMS | |
| Z-1716-2015 | Class II | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood... | Fresenius Medical Care Renal Therapies Group, LLC | KOC | |
| Z-1671-2015 | Class II | EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15... | Stryker Corp. | KNW | |
| Z-1680-2015 | Class II | D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact... | GE Healthcare | CCL | |
| Z-1643-2015 | Class II | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP... | Philips North America LLC | MUJ | |
| Z-1911-2015 | Class II | Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x... | Medtronic, Inc. | MSD | |
| Z-1910-2015 | Class II | Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x... | Medtronic, Inc. | MSD | |
| Z-1909-2015 | Class II | Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x... | Medtronic, Inc. | MSD |