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-1142-2017 | Class II | Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and... | Merge Healthcare Incorporated | HKI | |
| Z-0960-2017 | Class II | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product... | Trilliant Surgical LLC | HWC | |
| Z-0972-2017 | Class II | Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0971-2017 | Class II | Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1179-2017 | Class II | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative... | Ortho-Clinical Diagnostics, Inc. | JGP | |
| Z-1230-2017 | Class II | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital... | Cardiovascular Systems Incorporated | MCW | |
| Z-1023-2017 | Class II | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type... | Medacta USA, Inc. | KWP | |
| Z-0824-2017 | Class II | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-0823-2017 | Class II | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-0822-2017 | Class II | Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-0821-2017 | Class II | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-0820-2017 | Class II | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-0964-2017 | Class II | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401... | Stryker Sustainability Solutions | NLH | |
| Z-0963-2017 | Class II | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter... | Stryker Sustainability Solutions | NLH | |
| Z-0956-2017 | Class II | Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The... | Zimmer GmbH | HRY | |
| Z-0865-2017 | Class II | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife... | Accuray Incorporated | IYE | |
| Z-1019-2017 | Class II | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and... | Acumed LLC | MQV | |
| Z-0897-2017 | Class III | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative... | Revvity Health Sciences, Inc. | PJI | |
| Z-0686-2020 | Class II | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 | Polymer Technology Systems | LCP | |
| Z-0685-2020 | Class II | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 | Polymer Technology Systems | LCP | |
| Z-0684-2020 | Class II | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 | Polymer Technology Systems | LCP | |
| Z-0683-2020 | Class II | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 | Polymer Technology Systems | LCP | |
| Z-0682-2020 | Class II | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US... | Polymer Technology Systems | LCP | |
| Z-0052-2020 | Class II | K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick... | K2M, Inc | OLO | |
| Z-1396-2017 | Class II | McKesson Radiology 12.2 - Picture Archive Communication System (PACS) | Change Healthcare Canada Company | LLZ | |
| Z-1110-2017 | Class II | RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures. | Dilon Technologies France SAS | NPL | |
| Z-0990-2017 | Class II | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation... | Varian Medical Systems, Inc. | IYE | |
| Z-1185-2017 | Class II | Junction Box - 1104343 and 1193560 | Invacare GmbH | LLI | |
| Z-1184-2017 | Class II | Foot Section - BAR5490IVC | Invacare GmbH | LLI | |
| Z-1183-2017 | Class II | Bariatric Bed - BARPKG-IVC 1633 | Invacare GmbH | LLI | |
| Z-1182-2017 | Class II | Bariatric Bed - BAR600IVC | Invacare GmbH | LLI | |
| Z-1020-2017 | Class II | Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN... | Howmedica Osteonics Corp | LXH | |
| Z-0970-2017 | Class I | Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo... | Bard Peripheral Vascular Inc | DYB | |
| Z-0969-2017 | Class I | Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One... | Bard Peripheral Vascular Inc | DYB | |
| Z-0968-2017 | Class I | Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding... | Bard Peripheral Vascular Inc | DYB | |
| Z-0731-2017 | Class II | MOSAIQ Oncology Information System The product is used to manage workflows for... | Elekta Limited | IYE | |
| Z-0950-2017 | Class I | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N... | CareFusion 303, Inc | FRN | |
| Z-0949-2017 | Class II | PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic... | Merit Medical Systems, Inc. | DYB | |
| Z-0925-2017 | Class II | Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray... | Philips North America LLC | OWB | |
| Z-0924-2017 | Class II | Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging... | Philips North America LLC | OWB | |
| Z-0923-2017 | Class II | Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging... | Philips North America LLC | IZI | |
| Z-0942-2017 | Class II | TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical... | Pride Mobility Products Corp | ITI | |
| Z-0922-2017 | Class II | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging... | Philips North America LLC | OWB | |
| Z-0825-2017 | Class II | Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a... | Philips North America LLC | LNH | |
| Z-0902-2017 | Class II | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version... | Revvity Health Sciences, Inc. | JQP | |
| Z-1148-2017 | Class II | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2... | AtriCure, Inc. | FZP | |
| Z-0980-2017 | Class II | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext... | Abbott Medical | FMG | |
| Z-0753-2017 | Class III | Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. | Microtek Medical LLC | KKX | |
| Z-0874-2017 | Class II | 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally... | Stryker Corp. | HBE | |
| Z-0873-2017 | Class II | 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally... | Stryker Corp. | HBE |