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-0621-2012 | 3.5mm 90 Degree Part Number A1335-01 is an ablation wand Intended for resection... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0620-2012 | 3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0619-2012 | CoVac 70 Product Number AS3730-01 is an ablation wand Intended for resection, ablation... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0618-2012 | CoVac 50 Product Number AS2530-01 is an ablation wand Intended for resection, ablation... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0617-2012 | MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0616-2012 | SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection... | Innovatech Medical Resources L.P. | |||
| Z-0615-2012 | 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand | Innovatech Medical Resources L.P. | GEI | ||
| Z-0614-2012 | OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for... | Innovatech Medical Resources L.P. | MBI | ||
| Z-0613-2012 | OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer | Innovatech Medical Resources L.P. | KOG | ||
| Z-0612-2012 | OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation... | Innovatech Medical Resources L.P. | KOG | ||
| Z-0611-2012 | OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation... | Innovatech Medical Resources L.P. | GAT | ||
| Z-0610-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number... | Innovatech Medical Resources L.P. | MBI | ||
| Z-0609-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for... | Innovatech Medical Resources L.P. | MBI | ||
| Z-0608-2012 | OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator... | Innovatech Medical Resources L.P. | MBI | ||
| Z-0031-2012 | Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0838-2012 | Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use... | Lin-Zhi International Inc | DIF | ||
| Z-3184-2011 | Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant... | Straumann USA, LLC | LLZ | ||
| Z-3117-2011 | MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical... | Ansell Healthcare Products LLC | LZC | ||
| Z-3116-2011 | MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination... | Ansell Healthcare Products LLC | LZC | ||
| Z-3115-2011 | MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination... | Ansell Healthcare Products LLC | LZC | ||
| Z-3114-2011 | MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination... | Ansell Healthcare Products LLC | LZC | ||
| Z-1145-2012 | REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05... | Zimmer GmbH | JWH | ||
| Z-3070-2011 | Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift... | Arjo, Inc. | FSA | ||
| Z-0293-2012 | Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151... | Philips North America LLC | LNH | ||
| Z-3289-2011 | Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation... | Zimmer GmbH | LXH | ||
| Z-1079-2012 | UV-Absorbing Posterior Chamber IOL Model: SP-65A2, Serial Number: 1168471106... | Aaren Scientific Inc. | HQL | ||
| Z-1078-2012 | UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106... | Aaren Scientific Inc. | HQL | ||
| Z-1077-2012 | Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number... | Aaren Scientific Inc. | HQL | ||
| Z-1076-2012 | Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106... | Aaren Scientific Inc. | HQL | ||
| Z-0347-2013 | Class II | UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903... | Siemens Healthcare Diagnostics Inc. | CEM | |
| Z-0346-2013 | Class II | UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0345-2013 | Class II | UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1703-2012 | Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04... | Intel-Ge Care Innovations, LLC | IQA | ||
| Z-3160-2011 | Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L... | Picis Clinical Solutions, Inc. | NSX | ||
| Z-3053-2011 | Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No... | Boston Scientific Corporation | DQX | ||
| Z-3283-2011 | Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476... | Boston Scientific Corporation | LWS | ||
| Z-0056-2012 | 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The... | Boston Scientific Corporation | DYB | ||
| Z-0055-2012 | 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved... | Boston Scientific Corporation | DYB | ||
| Z-3041-2011 | Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR... | STERIS Corporation | MLR | ||
| Z-3107-2011 | GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use... | Abbott Medical | FRN | ||
| Z-1615-2012 | QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA)... | Intel-Ge Care Innovations, LLC | IQA | ||
| Z-3187-2011 | ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45... | Ethicon Endo-Surgery Inc | GDW | ||
| Z-3025-2011 | GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine... | Gyn-Disposables, Inc. | HDC | ||
| Z-3048-2011 | Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable... | Draeger Medical Systems, Inc. | MHX | ||
| Z-3047-2011 | Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable... | Draeger Medical Systems, Inc. | MHX | ||
| Z-0073-2012 | Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to... | Mizuho Orthopedic Systems Inc | JEA | ||
| Z-3017-2011 | Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion. | Animas Corp. | LZG | ||
| Z-3123-2011 | GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body... | GE Healthcare | LNH | ||
| Z-3122-2011 | GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The... | GE Healthcare | LNH | ||
| Z-3288-2011 | FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 | Respironics Novametrix, LLC. | BZK |