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-1167-2018 | Class II | SwishTapered Implant Intended for use in support for fixed bridgework. | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-1169-2018 | Class II | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-1350-2018 | Class II | Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product... | Neuropro Spinal Jaxx | MAX | |
| Z-1390-2018 | Class II | Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid... | Boston Scientific Corporation | OEQ | |
| Z-1151-2018 | Class II | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2520-2018 | Class II | Uretero-reno fiberscope URF-P6RP6 | OLYMPUS Corporation of the Americas | FGB | |
| Z-2519-2018 | Class II | Uretero-reno fiberscope URF-P6 | OLYMPUS Corporation of the Americas | FGB | |
| Z-2518-2018 | Class II | Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R | OLYMPUS Corporation of the Americas | OCS | |
| Z-0532-2018 | Class II | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1... | GE Healthcare | MSX | |
| Z-0646-2018 | Class II | Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with... | Medtronic Perfusion Systems | DTN | |
| Z-0645-2018 | Class II | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The... | Medtronic Perfusion Systems | DTN | |
| Z-2538-2019 | Class II | LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF... | Smith & Nephew, Inc. | JWH | |
| Z-0472-2019 | Class I | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0471-2019 | Class I | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-2923-2018 | Class II | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva... | Tecan U.S. | NHG | |
| Z-2378-2018 | Class II | BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-2060-2018 | Class II | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray... | Shimadzu Medical Systems | IZI | |
| Z-1378-2018 | Class II | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor... | Cook Incorporated | MQG | |
| Z-1377-2018 | Class II | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a... | Cook Incorporated | MQG | |
| Z-1512-2018 | Class II | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are... | Howmedica Osteonics Corp | MBH | |
| Z-1391-2018 | Class II | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat... | Samsung HME America, Inc. | MQB | |
| Z-1148-2018 | Class II | Artis one fluoroscopic x-ray system and patient table Artis one is an angiography... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1319-2018 | Class II | Progressa Bed - AC-powered adjustable hospital bed | Hill-Rom Inc. | FNL | |
| Z-0779-2018 | Class II | Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a... | Alcon Laboratories | HQC | |
| Z-0778-2018 | Class II | Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy... | Alcon Laboratories | HQC | |
| Z-0011-2019 | Class II | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A... | Nova Eye Inc. | HMX | |
| Z-1322-2018 | Class III | VITROS Immunodiagnostic Products TSH Reagent Pack | Clinical Diagnostic Systems, Inc. | JLW | |
| Z-1373-2018 | Class II | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver... | Trimed Inc | LXH | |
| Z-0841-2018 | Class II | IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed... | Philips North America LLC | JAK | |
| Z-0487-2018 | Class II | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE... | GE Medical Systems Information Technologies, Inc. | DQK | |
| Z-1340-2018 | Class II | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed... | Ethicon, Inc | NEW | |
| Z-1339-2018 | Class II | PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed... | Ethicon, Inc | NEW | |
| Z-1338-2018 | Class II | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed... | Ethicon, Inc | NEW | |
| Z-1261-2018 | Class II | Syngo.via software is intended to be used for viewing, manipulation, communication, and... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0777-2019 | Class III | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The... | Riverpoint Medical, LLC | IWJ | |
| Z-1296-2018 | Class II | LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative... | Magellan Diagnostics, Inc. | DOF | |
| Z-1295-2018 | Class II | LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R... | Magellan Diagnostics, Inc. | DOF | |
| Z-1303-2018 | Class II | Syngo.via. Medical Device Software. Picture archiving and communications system. | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0644-2018 | Class II | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature... | Innovasis, Inc | NKB | |
| Z-2574-2018 | Class III | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog... | Diamedix Corp. | GNP | |
| Z-2573-2018 | Class III | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No... | Diamedix Corp. | LJY | |
| Z-1775-2018 | Class II | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number... | Abbott Medical | DXQ | |
| Z-1150-2018 | Class II | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-2315-2018 | Class II | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power... | Canon Medical Systems USA, Inc. | IYN | |
| Z-2429-2018 | Class II | BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product... | bioMerieux, Inc. | JJE | |
| Z-2428-2018 | Class II | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product... | bioMerieux, Inc. | JJE | |
| Z-0716-2018 | Class II | Allura Xper systems with Certeray X-ray Generator located in regions with high mains... | Philips North America LLC | OWB | |
| Z-0553-2018 | Class II | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the... | The Binding Site Group Ltd. | DHR | |
| Z-0754-2019 | Class II | Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm... | Teleflex Medical | GEI | |
| Z-0753-2019 | Class II | Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm... | Teleflex Medical | GEI |