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-1905-2012 | Class II | TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model... | Invacare GmbH | ITI | |
| Z-1704-2012 | Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The... | Invacare GmbH | ITJ | ||
| Z-1431-2012 | Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer... | KCI USA, Inc. | FSA | ||
| Z-2014-2012 | Class II | Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are... | Etac Supply Center AB | ITJ | |
| Z-1650-2012 | Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact... | College Park Industries | ISH | ||
| Z-1516-2012 | Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS... | Siemens Healthcare Diagnostics Inc. | NBC | ||
| Z-1485-2012 | VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc... | Wright Medical Technology Inc | HSB | ||
| Z-1484-2012 | VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline... | Wright Medical Technology Inc | HSB | ||
| Z-1993-2012 | Class II | GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series... | GE Healthcare | IZL | |
| Z-1984-2012 | Class II | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra... | Integra LifeSciences Corporation | JXG | |
| Z-1494-2012 | Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0021-2013 | Class II | Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-1897-2012 | Class II | Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon... | Ethicon, Inc | LMF | |
| Z-1483-2012 | Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex... | Abbott Medical | NIK | ||
| Z-1482-2012 | Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite... | Abbott Medical | NIK | ||
| Z-1493-2012 | ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator)... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1486-2012 | Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1427-2012 | Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical... | Teleflex Medical | KOG | ||
| Z-1674-2012 | Water Pik Sinusense battery operated device including a blue semi-transparent water... | Water Pik, Inc. | KMA | ||
| Z-1464-2012 | Philips Digital Diagnost Systems with Eleva software version 2.x and stitching... | Philips North America LLC | MQB | ||
| Z-2487-2012 | Class II | Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill... | Howmedica Osteonics Corp | LZO | |
| Z-2082-2012 | Class II | Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is... | Hill-Rom Inc. | KNC | |
| Z-1935-2012 | Class II | Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick... | Greiner Bio-One North America, Inc. | FMI | |
| Z-1868-2012 | Class II | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable... | Medical Components, Inc. | LJT | |
| Z-1540-2012 | Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product... | Siemens Healthcare Diagnostics Inc. | MTF | ||
| Z-1462-2012 | Allura X-ray System. The Allura X-ray System is an angiographic X-ray system. | Philips North America LLC | IZI | ||
| Z-2430-2012 | Class III | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance... | ZOLL Medical Corporation | JCX | |
| Z-1675-2012 | Siemens MAGNETOM Essenza, Nuclear Magnetic Resonance Imaging System Product... | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1478-2012 | REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx... | Zimmer GmbH | HSB | ||
| Z-1437-2012 | ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed... | Teva Pharmaceuticals USA, Inc. | KDL | ||
| Z-1473-2012 | ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems... | Leica Microsystems, Inc. | IEO | ||
| Z-1465-2012 | MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6... | Medical Information Technology, Inc. | JQP | ||
| Z-1448-2012 | Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic... | Fresenius Medical Care Renal Therapies Group, LLC | FKX | ||
| Z-0715-2014 | Class II | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone... | The Anspach Effort, Inc. | HBE | |
| Z-0769-2014 | Class II | MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE | |
| Z-0768-2014 | Class II | MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in... | The Anspach Effort, Inc. | HBE | |
| Z-0767-2014 | Class II | MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE | |
| Z-0766-2014 | Class II | MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in... | The Anspach Effort, Inc. | HBE | |
| Z-0765-2014 | Class II | MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0764-2014 | Class II | MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE | |
| Z-0763-2014 | Class II | MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0762-2014 | Class II | MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0761-2014 | Class II | MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0760-2014 | Class II | MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0759-2014 | Class II | MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE | |
| Z-0758-2014 | Class II | MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in... | The Anspach Effort, Inc. | HBE | |
| Z-0757-2014 | Class II | MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE | |
| Z-0756-2014 | Class II | MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in... | The Anspach Effort, Inc. | HBE | |
| Z-0755-2014 | Class II | MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for... | The Anspach Effort, Inc. | HBE | |
| Z-0754-2014 | Class II | MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use... | The Anspach Effort, Inc. | HBE |