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-2318-2008 | Universal SlingBar 350 with Quick-release Hook Product Number: 3156084... | Liko AB | FSA | ||
| Z-2317-2008 | Universal SlingBar 600 Product Number: 3156076 Used with the: Viking XS... | Liko AB | FSA | ||
| Z-2316-2008 | Universal SlingBar 450 Product Number: 3156075 Used with the: Viking XS... | Liko AB | FSA | ||
| Z-2315-2008 | Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking S... | Liko AB | FSA | ||
| Z-0753-2016 | Class II | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a... | Regulatory Insight, Inc. | OWB | |
| Z-2560-2011 | Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to... | Elekta Limited | MUJ | ||
| Z-1710-2009 | G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and... | Volk Optical Inc | HKS | ||
| Z-0604-2009 | MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to... | Cordis US Corp. | KRA | ||
| Z-1447-2012 | ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate... | Abbott Medical | CIT | ||
| Z-2034-2008 | BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images... | Medtronic Navigation, Inc | JAA | ||
| Z-2414-2008 | Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff... | B Braun Medical Inc | FPA | ||
| Z-2413-2008 | Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff... | B Braun Medical Inc | FPA | ||
| Z-2412-2008 | Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic... | B Braun Medical Inc | FPA | ||
| Z-2411-2008 | Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88... | B Braun Medical Inc | FPA | ||
| Z-2410-2008 | Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The... | B Braun Medical Inc | FPA | ||
| Z-2409-2008 | Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122... | B Braun Medical Inc | FRN | ||
| Z-2408-2008 | Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The... | B Braun Medical Inc | FRN | ||
| Z-2407-2008 | Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj... | B Braun Medical Inc | FRN | ||
| Z-2037-2008 | GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server)... | GE Healthcare | HGM | ||
| Z-2301-2008 | Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a... | Zimmer GmbH | HWA | ||
| Z-2300-2008 | Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No... | Zimmer GmbH | LXH | ||
| Z-2299-2008 | Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05. | Zimmer GmbH | KWA | ||
| Z-2295-2008 | Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum... | Zimmer GmbH | JDY | ||
| Z-0306-2012 | ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is... | Acrymed Incorporated | FRO | ||
| Z-2305-2008 | Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with... | Abbott Medical | LZH | ||
| Z-2188-1991 | Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is... | Hologic, Inc. | KGI | ||
| Z-2187-2008 | Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is... | Hologic, Inc. | KGI | ||
| Z-2186-2008 | Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is... | Hologic, Inc. | KGI | ||
| Z-2185-2008 | Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is... | Hologic, Inc. | KGI | ||
| Z-2184-2008 | Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is... | Hologic, Inc. | KGI | ||
| Z-1972-2010 | Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting... | Microline Surgical, Inc | GEI | ||
| Z-2210-2010 | Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for... | Philips North America LLC | IZI | ||
| Z-2383-2008 | Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm... | Medtronic Neuromodulation | LKK | ||
| Z-2382-2008 | Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: Catheter... | Medtronic Neuromodulation | LKK | ||
| Z-2381-2008 | Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length markers... | Medtronic Neuromodulation | LKK | ||
| Z-2380-2008 | Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with length... | Medtronic Neuromodulation | LKK | ||
| Z-0029-2009 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded... | Applied Medical Resources Corp | GCJ | ||
| Z-0028-2009 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded... | Applied Medical Resources Corp | GCJ | ||
| Z-0027-2009 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii... | Applied Medical Resources Corp | GCJ | ||
| Z-0026-2009 | Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded... | Applied Medical Resources Corp | HET | ||
| Z-0025-2009 | Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded... | Applied Medical Resources Corp | HET | ||
| Z-0024-2009 | Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator... | Applied Medical Resources Corp | HET | ||
| Z-0023-2009 | Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded... | Applied Medical Resources Corp | HET | ||
| Z-2464-2008 | Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes... | Nebion, LLC | |||
| Z-2306-2008 | Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane... | Medtronic, Inc. | KNT | ||
| Z-2226-2008 | Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single... | Gyrus ACMI, Inc. | EYB | ||
| Z-0165-2009 | Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI... | Roche Diagnostics GmbH | JJE | ||
| Z-2361-2008 | Innova 2000 The principle system components include a C-arm, image acquisition... | GE Healthcare | MQB | ||
| Z-2360-2008 | Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems... | GE Healthcare | MQB | ||
| Z-2359-2008 | Advantx-E The Advantx imaging system is intended to be used for general purpose... | GE Healthcare | MQB |