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-3228-2017 | Class II | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... | Corcym Inc. | MRM | |
| Z-2870-2017 | Class II | X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat... | X-Laser LLC | REA | |
| Z-0089-2018 | Class II | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed... | Epimed International, Inc. | OGE | |
| Z-0088-2018 | Class II | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One... | Epimed International, Inc. | OGE | |
| Z-0087-2018 | Class II | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub... | Epimed International, Inc. | OGE | |
| Z-3100-2017 | Class II | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and... | Smith & Nephew, Inc. | LZO | |
| Z-0274-2018 | Class II | QIAamp DSP Virus Kit Cat. No. 60704 | Qiagen | N/A | |
| Z-0045-2020 | Class II | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name... | Helena Laboratories, Corp. | CFF | |
| Z-0941-2018 | Class II | Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216... | Howmedica Osteonics Corp | LPH | |
| Z-0940-2018 | Class II | Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 | Howmedica Osteonics Corp | LPH | |
| Z-0604-2018 | Class II | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | Synthes (USA) Products LLC | HSB | |
| Z-0419-2018 | Class II | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG... | Stryker Medical | DWJ | |
| Z-0293-2018 | Class I | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A... | Edwards Lifesciences LLC | NPT | |
| Z-3225-2017 | Class II | FUJINON ED-530XT. This device is intended for the visualization of the duodenum and... | FUJIFILM Healthcare Americas Corporation | FDT | |
| Z-0007-2018 | Class II | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only... | Implant Direct Sybron Manufacturing LLC | NHA | |
| Z-3118-2017 | Class II | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on... | Siemens Healthcare Diagnostics Inc. | LDP | |
| Z-1076-2018 | Class II | GENICON EZEE Retrieval, sterile, Rx only. | Genicon, Inc. | GCJ | |
| Z-3224-2017 | Class II | Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated... | Teleflex Medical | GEI | |
| Z-3223-2017 | Class II | Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is... | Teleflex Medical | GEI | |
| Z-3222-2017 | Class II | Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm... | Teleflex Medical | GEI | |
| Z-3221-2017 | Class II | Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments... | Teleflex Medical | GEI | |
| Z-3220-2017 | Class II | Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments... | Teleflex Medical | GEI | |
| Z-3219-2017 | Class II | Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm... | Teleflex Medical | GEI | |
| Z-3138-2017 | Class II | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle... | Kamiya Biomedical Company, LLC | JIX | |
| Z-0910-2018 | Class II | cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module | Roche Diagnostics GmbH | JJE | |
| Z-0909-2018 | Class II | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2... | Roche Diagnostics GmbH | JJE | |
| Z-0394-2018 | Class II | BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and... | Becton Dickinson & Co | NSU | |
| Z-0393-2018 | Class II | BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and... | Becton Dickinson & Co | NSU | |
| Z-0392-2018 | Class II | BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and... | Becton Dickinson & Co | NSU | |
| Z-0295-2018 | Class II | Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form... | MEDLINE INDUSTRIES, LP - Northfield | FQM | |
| Z-3080-2017 | Class II | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8"... | Jaeger Medical GmbH | CBT | |
| Z-0534-2018 | Class II | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge... | Medtronic, Inc. | GDY | |
| Z-0380-2018 | Class II | RayStation Product Usage: is a software system designed for treatment planning and... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0348-2018 | Class II | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips... | Philips North America LLC | MKJ | |
| Z-3087-2017 | Class I | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing... | Datascope Corp. | DSP | |
| Z-3086-2017 | Class I | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing... | Datascope Corp. | DSP | |
| Z-3085-2017 | Class I | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing... | Datascope Corp. | DSP | |
| Z-0847-2018 | Class II | A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product... | Datascope Corp. | BSZ | |
| Z-0846-2018 | Class II | A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and... | Datascope Corp. | BSZ | |
| Z-0554-2018 | Class II | TD60 Transmitter battery charger used with the BeneVision Central Station, Part number... | Datascope Corp. | MSX | |
| Z-0386-2018 | Class II | ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-0385-2018 | Class II | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-0311-2018 | Class II | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning... | Philips North America LLC | KPR | |
| Z-0517-2018 | Class II | PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 | Panoramic Rental Corp. | EHD | |
| Z-3126-2017 | Class II | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-3125-2017 | Class II | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-3124-2017 | Class II | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-3123-2017 | Class II | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-3122-2017 | Class II | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-3121-2017 | Class II | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for... | Leica Biosystems Richmond, Inc. | NJT |