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-0800-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-1200-06 | Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee. | Ossur Americas | ISY | ||
| Z-1199-06 | Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee. | Ossur Americas | ISY | ||
| Z-1198-06 | Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee. | Ossur Americas | ISY | ||
| Z-1197-06 | Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee. | Ossur Americas | ISY | ||
| Z-1445-06 | Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8... | Delphi Medical Systems | FRN | ||
| Z-0833-06 | Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data... | Baxter Healthcare Renal Div | KPF | ||
| Z-0832-06 | Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management... | Baxter Healthcare Renal Div | KPF | ||
| Z-0831-06 | Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module... | Baxter Healthcare Renal Div | KPF | ||
| Z-1161-06 | OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which... | bioMerieux, Inc. | MDB | ||
| Z-1170-06 | 62 RNR Series 2.5 microliter syringe without needle, Part#: 7632-01 | Hamilton Co | JQW | ||
| Z-1169-06 | Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for... | Hamilton Co | JQW | ||
| Z-0765-06 | VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro... | Ortho-Clinical Diagnostics, Inc. | CDP | ||
| Z-0712-06 | ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0704-06 | MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system. | GE Healthcare | JAA | ||
| Z-1434-06 | ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5... | ConMed Corporation | GEI | ||
| Z-1433-06 | ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple... | ConMed Corporation | GEI | ||
| Z-0841-06 | Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign... | Southwest Technologies Inc | FRO | ||
| Z-0757-06 | SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G | Fischer Imaging Corp. | MUE | ||
| Z-0708-06 | Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower... | FUJIFILM Healthcare Americas Corporation | FDF | ||
| Z-1526-06 | Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO... | Omarc LLC | KPJ | ||
| Z-1334-06 | ABX Pentra 120,120R,120DX, automated hematology analyzer | Horiba Instruments Incorporated | GKZ | ||
| Z-0454-06 | PlusRite Mercury Vapor Lamps | Fanlight Corporation Inc | U28 | ||
| Z-0453-06 | PlusRite Protected Metal Halide Lamps | Fanlight Corporation Inc | U28 | ||
| Z-0452-06 | PlusRite Universal Metal Halide Lamps | Fanlight Corporation Inc | U28 | ||
| Z-0451-06 | PlusRite Low Watt Metal Halide Lamps | Fanlight Corporation Inc | U28 | ||
| Z-0450-06 | PlusRite Power Strike Metal Halide Lamps | Fanlight Corporation Inc | U28 | ||
| Z-0798-06 | FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number... | Smith & Nephew, Inc. | KGS | ||
| Z-1322-06 | Capillary (end) caps, accessory for use with blood gas analyzers included in... | Radiometer America, Inc | GIO | ||
| Z-1321-06 | Capillary (end) caps, accessory for use with blood gas analyzers included in... | Radiometer America, Inc | GIO | ||
| Z-1085-06 | ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part... | Abbott Vascular | FGE | ||
| Z-1084-06 | ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part... | Abbott Vascular | FGE | ||
| Z-1083-06 | Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)... | Abbott Vascular | FGE | ||
| Z-1082-06 | Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)... | Abbott Vascular | FGE | ||
| Z-1081-06 | Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)... | Abbott Vascular | FGE | ||
| Z-0834-06 | Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic... | Fresenius Medical Care Renal Therapies Group, LLC | FKX | ||
| Z-1080-06 | Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base... | Abbott Vascular | FGE | ||
| Z-0843-06 | Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter... | Celsion Corporation | MEQ | ||
| Z-0711-06 | LIFEPAK 20 defibrillator/monitor | Physio Control, Inc. | LDD | ||
| Z-0710-06 | LIFEPAK 12 defibrillator/monitor | Physio Control, Inc. | MKJ | ||
| Z-1196-06 | Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The... | GE Healthcare | BSZ | ||
| Z-0870-06 | ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured... | Excelsior Medical LLC | FRN | ||
| Z-0808-06 | Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a... | Respironics, Inc. | CBK | ||
| Z-1212-06 | Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL | Stryker Sustainability Solutions | NLM | ||
| Z-1105-06 | MRP-7000, AIRIS Magnetic Resonance Imaging Systems | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0873-06 | Sterile packaged wound dressing with white and green inner pouch and outer carton labels... | KCI USA, Inc. | FTL | ||
| Z-0929-06 | Anestar and Anestar Plus Anesthesia System. | Datascope Corp. | BSZ | ||
| Z-0797-06 | SOMATOM Sensation CT Systems | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0295-2007 | LIFEPAK 20 automatic external defibrillator | Physio Control, Inc. | LDD | ||
| Z-1376-06 | ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter | Siemens Healthcare Diagnostics Inc. | GKL |