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-2661-2017 | Class II | Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO | Medacta USA, Inc. | KRO | |
| Z-2196-2017 | Class II | GE Healthcare Discovery NM/CT 570c X-ray system | GE Healthcare | KPS | |
| Z-2195-2017 | Class II | GE Healthcare Discovery NM/CT 670 CZT X-ray system | GE Healthcare | KPS | |
| Z-2194-2017 | Class II | GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system | GE Healthcare | KPS | |
| Z-2193-2017 | Class II | GE Healthcare Discovery Ml X-ray system | GE Healthcare | KPS | |
| Z-2192-2017 | Class II | GE Healthcare Discovery IQ X-ray system | GE Healthcare | KPS | |
| Z-2191-2017 | Class II | GE Healthcare Discovery Ml DR X-ray system | GE Healthcare | KPS | |
| Z-2190-2017 | Class II | GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system | GE Healthcare | KPS | |
| Z-2189-2017 | Class II | GE Healthcare Lightspeed RT16 X-ray system | GE Healthcare | JAK | |
| Z-2188-2017 | Class II | GE Healthcare BrightSpeed X-ray system | GE Healthcare | JAK | |
| Z-2187-2017 | Class II | GE Healthcare lnnova IGS 540 ACT X-ray system | GE Healthcare | JAK | |
| Z-2186-2017 | Class II | GE Healthcare Optima CT540 X-ray system | GE Healthcare | JAK | |
| Z-2185-2017 | Class II | GE Healthcare Optima CT520 X-ray system | GE Healthcare | JAK | |
| Z-2184-2017 | Class II | GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system | GE Healthcare | JAK | |
| Z-2183-2017 | Class II | GE Healthcare LightSpeed VCT X-ray system | GE Healthcare | JAK | |
| Z-2182-2017 | Class II | GE Healthcare Optima CT660, CT680 X-ray system | GE Healthcare | JAK | |
| Z-2181-2017 | Class II | GE Healthcare Revolution EVO X-ray system | GE Healthcare | JAK | |
| Z-2623-2017 | Class II | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J | Artivion, Inc. | MUQ | |
| Z-2763-2017 | Class II | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5... | Fisher Diagnostics | KQJ | |
| Z-2762-2017 | Class II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations)... | Fisher Diagnostics | KQJ | |
| Z-0212-2018 | Class II | PENTARAY NAV High-Density Mapping Catheter. | Biosense Webster Inc | MTD | |
| Z-0211-2018 | Class II | PENTARAY NAV High-Density Mapping Catheter. | Biosense Webster Inc | MTD | |
| Z-2247-2017 | Class II | KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. | Medtronic Sofamor Danek USA Inc | OAR | |
| Z-2612-2017 | Class II | QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part... | Z-Medica, LLC | FRO | |
| Z-0201-2018 | Class II | Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech... | Exactech, Inc. | HSN | |
| Z-0200-2018 | Class II | Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc... | Exactech, Inc. | HSN | |
| Z-2770-2017 | Class II | VITEK 2 Gram Negative test kits containing colistin (cs01n) | bioMerieux, Inc. | PTJ | |
| Z-2688-2017 | Class II | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-3132-2017 | Class II | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to... | Boston Scientific Corporation | DRG | |
| Z-2730-2017 | Class II | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-2339-2017 | Class II | VIDAS Testosterone, Ref 30418 | bioMerieux, Inc. | CDZ | |
| Z-2589-2017 | Class II | CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD... | Abbott Medical | FPA | |
| Z-2685-2017 | Class II | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06... | Revvity Health Sciences, Inc. | JJN | |
| Z-2550-2018 | Class II | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in... | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-2159-2017 | Class II | MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No... | Mesa Laboratories Inc | FKH | |
| Z-2619-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product... | DePuy Mitek, Inc. | HWC | |
| Z-2618-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The... | DePuy Mitek, Inc. | HWC | |
| Z-2617-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product... | DePuy Mitek, Inc. | HWC | |
| Z-2616-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The... | DePuy Mitek, Inc. | HWC | |
| Z-2615-2017 | Class II | DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product... | DePuy Mitek, Inc. | HWC | |
| Z-3029-2017 | Class II | Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic... | GE Healthcare | LNH | |
| Z-3028-2017 | Class II | 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T... | GE Healthcare | LNH | |
| Z-3027-2017 | Class II | 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa... | GE Healthcare | LNH | |
| Z-3026-2017 | Class II | SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is... | GE Healthcare | LNH | |
| Z-3025-2017 | Class II | Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a... | GE Healthcare | LNH | |
| Z-3024-2017 | Class II | Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic... | GE Healthcare | LNH | |
| Z-3023-2017 | Class II | Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic... | GE Healthcare | LNH | |
| Z-3022-2017 | Class II | Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body... | GE Healthcare | LNH | |
| Z-3021-2017 | Class II | Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body... | GE Healthcare | LNH | |
| Z-0171-2018 | Class II | BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171... | Becton Dickinson & Co | LON |