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-2284-2018 | Class II | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)... | Ion Beam Applications S.A. | LHN | |
| Z-1814-2016 | Class II | PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the... | Zimmer GmbH | FMF | |
| Z-1996-2016 | Class II | EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd... | Ethicon, Inc | GEL | |
| Z-2001-2016 | Class II | Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part... | Natus Medical Incorporated | LBI | |
| Z-0115-2018 | Class II | ROSA Surgical Device 2.5.8 | Zimmer GmbH | HAW | |
| Z-1426-2017 | Class II | DR Systems Unity PACS software, now known as Merge Unity PACS | Merge Healthcare Incorporated | LLZ | |
| Z-1385-2017 | Class II | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge... | Merge Healthcare Incorporated | LLZ | |
| Z-1875-2016 | Class II | Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce... | Philips North America LLC | JAK | |
| Z-1874-2016 | Class II | Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce... | Philips North America LLC | JAK | |
| Z-1873-2016 | Class II | Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce... | Philips North America LLC | JAK | |
| Z-1872-2016 | Class II | Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce... | Philips North America LLC | JAK | |
| Z-1711-2016 | Class II | SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse... | Limacorporate S.p.A. | KWS | |
| Z-1602-2016 | Class II | Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in... | Medtronic Powered Surgical Solutions | HBB | |
| Z-1592-2016 | Class II | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-1844-2016 | Class II | EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide... | Skytron, LLC | GDC | |
| Z-2280-2016 | Class II | Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic... | PENTAX of America, Inc. | FAM | |
| Z-2279-2016 | Class II | Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of... | PENTAX of America, Inc. | ODG | |
| Z-2278-2016 | Class II | Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic... | PENTAX of America, Inc. | FDF | |
| Z-2277-2016 | Class II | Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic... | PENTAX of America, Inc. | FDT | |
| Z-2276-2016 | Class II | Confocal GI Scope Product Usage: Intended to provide optical visualization of and... | PENTAX of America, Inc. | GCJ | |
| Z-2275-2016 | Class II | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic... | PENTAX of America, Inc. | FDF | |
| Z-2080-2016 | Class II | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted... | PENTAX of America, Inc. | FGB | |
| Z-2079-2016 | Class II | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to... | PENTAX of America, Inc. | FGB | |
| Z-2078-2016 | Class II | Ureteroscope Intended to provide optical visualization of and therapeutic access to the... | PENTAX of America, Inc. | FGB | |
| Z-2077-2016 | Class II | Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic... | PENTAX of America, Inc. | ITX | |
| Z-2076-2016 | Class II | Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic... | PENTAX of America, Inc. | EOQ | |
| Z-2075-2016 | Class II | Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the... | PENTAX of America, Inc. | FAM | |
| Z-2074-2016 | Class II | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic... | PENTAX of America, Inc. | EOB | |
| Z-2073-2016 | Class II | Laryngo Stroboscope Product Usage Intended to provide optical visualization of... | PENTAX of America, Inc. | EQL | |
| Z-2072-2016 | Class II | Intubation Scope Intended to provide optical visualization of, therapeutic access to, and... | PENTAX of America, Inc. | CAL | |
| Z-2071-2016 | Class II | Gastroscope Intended to provide optical visualization of and therapeutic access to the... | PENTAX of America, Inc. | FDS | |
| Z-2070-2016 | Class II | Cystoscope Intended to provide optical visualization of and therapeutic access to the... | PENTAX of America, Inc. | FAJ | |
| Z-2069-2016 | Class II | Confocal GI Scope Intended to provide optical visualization of an therapeutic access to... | PENTAX of America, Inc. | GCJ | |
| Z-2068-2016 | Class II | Colonoscope Intended to provide optical visualization of and therapeutic access to the... | PENTAX of America, Inc. | FDF | |
| Z-2067-2016 | Class II | Choledochoscope Intended to provide optical visualization of and therapeutic access to... | PENTAX of America, Inc. | FBN | |
| Z-2066-2016 | Class II | Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic... | PENTAX of America, Inc. | FBN | |
| Z-2065-2016 | Class II | Bronchoscope Intended to provide optical visualization of and therapeutic access to the... | PENTAX of America, Inc. | EOQ | |
| Z-1914-2016 | Class II | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1913-2016 | Class II | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1600-2016 | Class II | Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For... | Nuvectra Corporation | LGW | |
| Z-2254-2016 | Class II | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA... | Roche Molecular Systems Inc | OWD | |
| Z-2047-2016 | Class II | Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ... | Ceg Enterprises LLC | MCF | |
| Z-1877-2016 | Class II | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment... | Leica Microsystems, Inc. | NJT | |
| Z-1876-2016 | Class II | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is... | Leica Microsystems, Inc. | NJT | |
| Z-2643-2017 | Class II | MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number... | Merge Healthcare Incorporated | DQA | |
| Z-2642-2017 | Class II | MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric... | Merge Healthcare Incorporated | DQA | |
| Z-2641-2017 | Class II | Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product... | Merge Healthcare Incorporated | DQA | |
| Z-2640-2017 | Class II | SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product... | Merge Healthcare Incorporated | DQK | |
| Z-1762-2017 | Class II | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge... | Merge Healthcare Incorporated | LMB | |
| Z-1778-2017 | Class II | Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland... | Merge Healthcare Incorporated | DQK |