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-0988-2017 | Class II | Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended... | Abbott Medical | FPA | |
| Z-0330-2017 | Class II | Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory... | Azer Scientific, Inc. | MRV | |
| Z-0329-2017 | Class II | Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles... | Azer Scientific, Inc. | MRV | |
| Z-0082-2017 | Class II | SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US... | Siemens Healthcare Diagnostics Inc. | LFX | |
| Z-0081-2017 | Class II | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS)... | Siemens Healthcare Diagnostics Inc. | LFX | |
| Z-0007-2017 | Class I | 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and... | Baxter Corporation Englewood | LHI | |
| Z-2868-2016 | Class II | PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed... | Integra Pain Management | CAZ | |
| Z-2733-2016 | Class II | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND | Integra Pain Management | HBG | |
| Z-2759-2016 | Class II | WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation... | Teleflex Medical | GDO | |
| Z-2887-2016 | Class II | R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of... | R & D Systems, Inc. | JNM | |
| Z-2910-2016 | Class II | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC... | Integra LifeSciences Corporation | JXG | |
| Z-2909-2016 | Class II | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in... | Integra LifeSciences Corporation | JXG | |
| Z-2908-2016 | Class II | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek... | Integra LifeSciences Corporation | JXG | |
| Z-2907-2016 | Class II | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC... | Integra LifeSciences Corporation | JXG | |
| Z-2906-2016 | Class II | CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged... | Integra LifeSciences Corporation | JXG | |
| Z-2905-2016 | Class II | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek... | Integra LifeSciences Corporation | JXG | |
| Z-2890-2016 | Class II | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion... | EKOS Corporation | FOX | |
| Z-2869-2016 | Class II | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. | Hologic, Inc. | KNW | |
| Z-0067-2017 | Class II | The Introes Pocket Bougie is an endotracheal tube introducer. The device is an... | Bomimed Inc | BSR | |
| Z-0016-2017 | Class II | Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000... | Panoramic Rental Corp. | EHD | |
| Z-0060-2017 | Class II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200... | Howmedica Osteonics Corp | HWA | |
| Z-2680-2016 | Class II | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism... | Waismed Ltd. | FMI | |
| Z-2767-2016 | Class II | Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY... | Novadaq Technologies ULC | IZI | |
| Z-2691-2016 | Class II | HexaPOD evo RT System Product Usage: The intended use of the device is the control of... | Elekta Limited | IYE | |
| Z-2712-2016 | Class II | Monaco RTP System Used to make treatment plans for patients with prescriptions for... | Elekta Limited | MUJ | |
| Z-0112-2017 | Class II | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty... | Stryker Corp. | HWE | |
| Z-0006-2017 | Class I | HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... | HeartWare, Inc. | DSQ | |
| Z-0646-2017 | Class II | Pathfast D-Dimer, Reference number: PF1051-KUS | Lsi Medience Corporation | GHH | |
| Z-2752-2016 | Class II | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold... | Zimmer GmbH | JDC | |
| Z-0318-2017 | Class II | Pentax Video Gastroscope is intended to be used with a Pentax video processor (including... | PENTAX of America, Inc. | FDS | |
| Z-0636-2017 | Class II | Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including... | PENTAX of America, Inc. | FDF | |
| Z-2897-2016 | Class II | BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003... | Prismatik Dentalcraft, Inc. | EIH | |
| Z-2776-2016 | Class II | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C... | Biosense Webster Inc | DQK | |
| Z-0008-2017 | Class II | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852... | Microgenics Corporation | OUF | |
| Z-2890-2018 | Class II | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product... | Wenzel Spine | LLZ | |
| Z-2918-2016 | Class III | Arthrex Suture Washer | Arthrex GmbH | HTN | |
| Z-0649-2017 | Class II | Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and... | Merit Medical Systems, Inc. | FPA | |
| Z-2659-2016 | Class II | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture... | Novarad Corp. | LLZ | |
| Z-2757-2016 | Class II | Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary... | LivaNova USA, Inc. | DWF | |
| Z-2756-2016 | Class II | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number... | LivaNova USA, Inc. | DWF | |
| Z-2651-2016 | Class II | Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT... | Medtronic, Inc. | LWS | |
| Z-2650-2016 | Class II | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... | Medtronic, Inc. | LWS | |
| Z-2681-2016 | Class II | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028... | Philips North America LLC | LLZ | |
| Z-2746-2016 | Class II | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element... | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-0092-2017 | Class II | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales... | Ortho-Clinical Diagnostics, Inc. | KNK | |
| Z-0091-2017 | Class II | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales... | Ortho-Clinical Diagnostics, Inc. | CDT | |
| Z-0090-2017 | Class II | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales... | Ortho-Clinical Diagnostics, Inc. | KHP | |
| Z-0089-2017 | Class II | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales... | Ortho-Clinical Diagnostics, Inc. | CGA | |
| Z-2679-2016 | Class II | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O, | DeRoyal Industries, Inc. | LRO | |
| Z-2678-2016 | Class II | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit. | DeRoyal Industries, Inc. | LRO |