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-0961-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0960-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,(... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0721-2007 | Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of... | Urologix, LLC | MEQ | ||
| Z-0720-2007 | Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of... | Urologix, LLC | MEQ | ||
| Z-0736-2007 | Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400... | Roche Diagnostics GmbH | KXT | ||
| Z-0739-2007 | Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and... | Philips North America LLC | IZW | ||
| Z-0905-2007 | FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the... | Varian Medical Systems, Inc. | IYE | ||
| Z-0755-2007 | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the... | Diasorin Inc. | LLM | ||
| Z-0730-2007 | Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number... | Conmed Endoscopic Technologies, Inc. | FGE | ||
| Z-0729-2007 | Flexxus™ Endoscopic Biliary Stent, 7.5 Fr 10mm diameter x 40 mm length Item Number... | Conmed Endoscopic Technologies, Inc. | FGE | ||
| Z-0866-2007 | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref... | Smith & Nephew, Inc. | LXH | ||
| Z-0865-2007 | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref... | Smith & Nephew, Inc. | LXH | ||
| Z-0864-2007 | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref... | Smith & Nephew, Inc. | LXH | ||
| Z-0863-2007 | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref... | Smith & Nephew, Inc. | LXH | ||
| Z-0862-2007 | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref... | Smith & Nephew, Inc. | LXH | ||
| Z-0853-2007 | STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay... | Diagnostica Stago, Inc. | GGP | ||
| Z-1164-2007 | BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc... | BioHorizons Implant Systems Inc | DZE | ||
| Z-0694-2007 | BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc... | BioHorizons Implant Systems Inc | DZE | ||
| Z-0693-2007 | BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc... | BioHorizons Implant Systems Inc | DZE | ||
| Z-0692-2007 | BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham... | BioHorizons Implant Systems Inc | DZE | ||
| Z-0760-2007 | Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX... | Medtronic, Inc. | CBK | ||
| Z-0200-2009 | Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2... | GE Healthcare | IZO | ||
| Z-0659-2008 | da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive... | Intuitive Surgical, Inc. | NAY | ||
| Z-0658-2008 | da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive... | Intuitive Surgical, Inc. | NAY | ||
| Z-0657-2008 | da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive... | Intuitive Surgical, Inc. | NAY | ||
| Z-0978-2007 | LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0... | Varian Medical Systems, Inc. | IYE | ||
| Z-0735-2007 | AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc. | Roche Molecular Systems Inc | NTI | ||
| Z-0734-2007 | AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics | Roche Molecular Systems Inc | NTI | ||
| Z-0855-2007 | ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test... | Abbott Medical | MMI | ||
| Z-0757-2007 | PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY... | ConMed Corporation | MLN | ||
| Z-0756-2007 | PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Mo... | ConMed Corporation | MLN | ||
| Z-0132-2008 | VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San... | Vnus Medical Technologies, Inc. | GEI | ||
| Z-0717-2007 | Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386. | Eastman Kodak Company | KPR | ||
| Z-0738-2007 | Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary... | Eastman Kodak Company | KPR | ||
| Z-0716-2007 | QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface... | Pulse Biomedical, Inc. | LOS | ||
| Z-0856-2007 | Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. | Abbott Medical | NBW | ||
| Z-0715-2007 | Contact lens solution. The product is distributed under the following trade names... | Bausch & Lomb Incorporated | LYL | ||
| Z-0858-2010 | Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-0672-2007 | BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618 | Becton Dickinson & Co | KYG | ||
| Z-0671-2007 | LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated... | Physio Control, Inc. | MKJ | ||
| Z-0683-2007 | OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt... | GE Healthcare | JAA | ||
| Z-0682-2007 | OEC 9800 Plus (Fluorotrak), Image-intensified fluoroscopic x-ray system, GE Healthcare... | GE Healthcare | JAA | ||
| Z-0180-2008 | Philips, Voxel Q workstations, untilizing AcQSim or AcQPlan software version 4.2, 4.2.1... | Philips North America LLC | JAK | ||
| Z-0681-2007 | OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE... | GE Healthcare | JAA | ||
| Z-0680-2007 | OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, GE Healthcare... | GE Healthcare | JAA | ||
| Z-0679-2007 | OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE... | GE Healthcare | JAA | ||
| Z-0758-2007 | Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and... | Teleflex Medical | CCW | ||
| Z-0726-2007 | Smith & Nephew Suture Passer 2 inch Part Number : 7209167 | Smith & Nephew, Inc. | NBW | ||
| Z-0725-2007 | Smith & Nephew Suture Passer 12 inch Part Number 7209166D (refurbished) | Smith & Nephew, Inc. | NBW | ||
| Z-0724-2007 | Smith & Nephew Suture Passer 12 inch Part Number: 7209166 | Smith & Nephew, Inc. | NBW |