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-1150-2007 | Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing... | Zinnanti Surgical Design LLC | GEI | ||
| Z-0260-2008 | Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm... | Boston Scientific Corporation | DQY | ||
| Z-0259-2008 | Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm... | Boston Scientific Corporation | DQY | ||
| Z-1197-2007 | Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The... | Alcon Laboratories | HMX | ||
| Z-0298-2008 | Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0297-2008 | Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-1203-2007 | Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden | Maquet Cardiovascular Us Sales, LLC | BSZ | ||
| Z-1239-2007 | Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS... | Howmedica Osteonics Corp | NKB | ||
| Z-2135-2008 | Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical... | Acumed LLC | HWC | ||
| Z-0036-2008 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive... | Kulzer GmbH | KLE | ||
| Z-0035-2008 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive... | Kulzer GmbH | KLE | ||
| Z-1764-2008 | HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the... | DiaSorin Molecular LLC | LGC | ||
| Z-0113-2008 | GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and... | GE Healthcare | IYO | ||
| Z-1222-2007 | ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL... | Abbott Medical | JJX | ||
| Z-0990-2007 | GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. | GE Healthcare | JAA | ||
| Z-0989-2007 | GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake... | GE Healthcare | JAA | ||
| Z-0182-2008 | Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes... | Pacific Bioscience Lab, Inc. | FLG | ||
| Z-1205-2007 | Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section... | Deroyal Industries, Inc. Lafollette | KDD | ||
| Z-1204-2007 | Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx... | Deroyal Industries, Inc. Lafollette | KDD | ||
| Z-1174-2007 | EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1158-2010 | Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for... | Elekta Limited | IWB | ||
| Z-1526-2008 | GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00... | GE Healthcare | CBK | ||
| Z-2153-2008 | Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal... | Acumed LLC | HRS | ||
| Z-0959-2008 | Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0958-2008 | Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1210-2007 | Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia... | Avazzia, Inc | GZJ | ||
| Z-1209-2007 | Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured... | Avazzia, Inc | GZJ | ||
| Z-1208-2007 | Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc... | Avazzia, Inc | GZJ | ||
| Z-1119-2007 | Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808... | Dentium USA | DZE | ||
| Z-1207-2007 | Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by... | Avazzia, Inc | GZJ | ||
| Z-1168-2007 | Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm... | Cook Incorporated | FAD | ||
| Z-1245-2008 | IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the... | AGFA Healthcare Corp. | LLZ | ||
| Z-0317-2008 | Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees... | Zimmer GmbH | LXH | ||
| Z-0316-2008 | Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees... | Zimmer GmbH | LXH | ||
| Z-0327-2008 | Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part... | Mini-Mitter Co., Inc. | M | ||
| Z-0326-2008 | Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a... | Mini-Mitter Co., Inc. | M | ||
| Z-1238-2007 | Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa... | Baxter Corporation Englewood | NEP | ||
| Z-0325-2008 | Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend... | Mini-Mitter Co., Inc. | M | ||
| Z-0324-2008 | Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part... | Mini-Mitter Co., Inc. | M | ||
| Z-0571-2008 | Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with... | Ventana Medical Systems Inc | NQN | ||
| Z-1184-2007 | Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with... | Arizant Healthcare, Inc. | FPA | ||
| Z-1183-2007 | Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with... | Arizant Healthcare, Inc. | FPA | ||
| Z-1191-2007 | Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 | Boston Scientific Corporation | DRF | ||
| Z-1181-2007 | PhaSeal, Protector 50, Item No. 50, US Order No. 10310 | Carmel Pharma AB. | FPA | ||
| Z-1180-2007 | PhaSeal, Protector 21, Item No. 21, US Order No. 22020 | Carmel Pharma AB. | FPA | ||
| Z-1179-2007 | PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 | Carmel Pharma AB. | FPA | ||
| Z-1178-2007 | PhaSeal, Protector 14, Item No. P14, US Order No. 21320 | Carmel Pharma AB. | FPA | ||
| Z-0040-2008 | Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the... | Medtronic Neuromodulation | EZW | ||
| Z-1194-2007 | Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370. | Zimmer GmbH | KWS | ||
| Z-0213-2008 | Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology... | Varian Medical Systems, Inc. | KPQ |