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-1278-2018 | Class II | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1796-2018 | Class II | Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric... | Siemens Healthcare Diagnostics Inc. | CHI | |
| Z-1305-2018 | Class II | Dynavox T15 Speech Generating Device ( including Batteries) | Tobii Dynavox LLC | ILQ | |
| Z-1304-2018 | Class II | Dynavox T10 Speech Generating Device ( including Batteries) | Tobii Dynavox LLC | ILQ | |
| Z-0688-2018 | Class II | PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog... | Merit Medical Systems, Inc. | DYB | |
| Z-0564-2018 | Class II | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that... | Kalila Medical, Inc. | DYB | |
| Z-0563-2018 | Class II | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a... | Kalila Medical, Inc. | DYB | |
| Z-2064-2018 | Class II | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx... | C.R. Bard Inc | EZC | |
| Z-1614-2018 | Class II | 11-VI Incorporated Laser diode component Non-certified laser diode component used in... | Ii - Vi Incorporated | N/A | |
| Z-1237-2018 | Class II | Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power... | Medtronic, Inc. | GDW | |
| Z-1277-2018 | Class II | CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic... | Halyard Health | FPB | |
| Z-0409-2018 | Class II | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A... | Smith & Nephew, Inc. | OSN | |
| Z-1104-2018 | Class II | Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot... | Boston Scientific Corporation | GBO | |
| Z-1103-2018 | Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN... | Boston Scientific Corporation | GBO | |
| Z-1102-2018 | Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN... | Boston Scientific Corporation | GBO | |
| Z-1101-2018 | Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The... | Boston Scientific Corporation | GBO | |
| Z-1100-2018 | Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The... | Boston Scientific Corporation | GBO | |
| Z-1099-2018 | Class II | Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980... | Boston Scientific Corporation | GBW | |
| Z-1224-2018 | Class II | PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients... | Zimmer GmbH | JHW | |
| Z-0329-2018 | Class II | EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For... | Encore Medical, LP | JWH | |
| Z-0328-2018 | Class II | EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For... | Encore Medical, LP | JWH | |
| Z-0327-2018 | Class II | EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use... | Encore Medical, LP | JWH | |
| Z-0326-2018 | Class II | DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use... | Encore Medical, LP | JWH | |
| Z-2735-2018 | Class II | Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular... | Boston Scientific Corporation | DQY | |
| Z-2043-2018 | Class II | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) /... | Medical Action Industries, Inc. 306 | FRL | |
| Z-1536-2018 | Class II | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 | Smith & Nephew, Inc. | MAI | |
| Z-0704-2018 | Class II | digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital... | Philips North America LLC | MQB | |
| Z-0562-2018 | Class II | Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a... | Philips North America LLC | JAK | |
| Z-0397-2018 | Class II | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System... | Smith & Nephew, Inc. | HRS | |
| Z-0396-2018 | Class II | smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System... | Smith & Nephew, Inc. | HRS | |
| Z-0607-2018 | Class II | Synvisc-One (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A... | Sanofi Genzyme Corp. | MOZ | |
| Z-2266-2018 | Class II | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE... | GE Healthcare | CBK | |
| Z-1535-2018 | Class II | Widefield OCT software feature for the Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | |
| Z-1585-2018 | Class II | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System... | FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | IYE | |
| Z-0980-2018 | Class II | Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total... | Zimmer GmbH | HSD | |
| Z-0979-2018 | Class II | Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total... | Zimmer GmbH | HSD | |
| Z-0923-2018 | Class II | ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT... | Abbott Medical | JJE | |
| Z-0922-2018 | Class II | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT... | Abbott Medical | JJE | |
| Z-0921-2018 | Class II | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT... | Abbott Medical | JJE | |
| Z-0290-2018 | Class II | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product... | Remel Inc | GNB | |
| Z-2761-2019 | Class II | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label... | Helena Laboratories, Corp. | GFO | |
| Z-1064-2018 | Class II | 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327... | Zimmer GmbH | HWC | |
| Z-0377-2018 | Class II | PROPONENT MRI Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0376-2018 | Class II | PROPONENT VDD SL Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0375-2018 | Class II | PROPONENT EL DR Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0374-2018 | Class II | PROPONENT DR Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0373-2018 | Class II | PROPONENT SR Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0372-2018 | Class II | ESSENTIO MRI EL DR Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0371-2018 | Class II | ESSENTIO EL DR Pacemaker | Boston Scientific Corporation | LWP | |
| Z-0370-2018 | Class II | ESSENTIO MRI DR Pacemaker | Boston Scientific Corporation | LWP |