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-0755-2016 | Class II | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0798-2016 | Class I | Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic... | Cook Incorporated | DQO | |
| Z-0280-2016 | Class II | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | LivaNova USA, Inc. | LYJ | |
| Z-0182-2016 | Class II | ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0192-2016 | Class II | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The... | Synthes (USA) Products LLC | EZX | |
| Z-0213-2016 | Class II | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x... | Ivoclar Vivadent, Inc. | EBC | |
| Z-0194-2016 | Class II | Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path | Baxter Healthcare Corporation | KDJ | |
| Z-0167-2016 | Class II | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini... | Synthes (USA) Products LLC | HRS | |
| Z-2592-2016 | Class II | Mammography | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-2591-2016 | Class II | Pediatric Kidney Biopsy Tray | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-2590-2016 | Class II | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-2589-2016 | Class II | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | |
| Z-0198-2016 | Class III | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of... | C.R. Bard Inc | MJC | |
| Z-0238-2016 | Class II | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro... | DiaSorin Molecular LLC | OTT | |
| Z-0169-2016 | Class II | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model... | Welch Allyn Inc | HIB | |
| Z-0730-2017 | Class II | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store... | Merge Healthcare Incorporated | LLZ | |
| Z-0395-2016 | Class II | The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the... | Powers Medical Devices, LLC | HCC | |
| Z-1636-2016 | Class I | ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood... | Hummingbird Med | KST | |
| Z-0242-2016 | Class II | Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000)... | WalkMed Technologies, LLC | FRN | |
| Z-1066-2016 | Class II | Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and... | Philips North America LLC | OWB | |
| Z-2731-2017 | Class II | Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221... | O-Two Medical Technologies, Inc. | NAE | |
| Z-0339-2016 | Class II | Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158... | Siemens Healthcare Diagnostics Inc. | JGJ | |
| Z-0251-2016 | Class II | Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. | Shimadzu Medical Systems | JAA | |
| Z-0171-2016 | Class III | BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts... | Becton, Dickinson and Company, BD Biosciences | LIZ | |
| Z-0237-2016 | Class II | TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 | Tekia Inc | HQL | |
| Z-0249-2016 | Class II | Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF... | Howmedica Osteonics Corp | JWH | |
| Z-0271-2016 | Class I | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to... | Alcon Laboratories | HQL | |
| Z-0203-2016 | Class II | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The... | Highridge Medical, LLC | KWQ | |
| Z-0200-2016 | Class II | Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable... | Medtronic, Inc. | DRF | |
| Z-0809-2016 | Class II | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery... | Exactech, Inc. | OVE | |
| Z-0226-2016 | Class II | The Centricity Universal Viewer Version is a device that displays medical images... | GE Healthcare | LLZ | |
| Z-0225-2016 | Class II | The Centricity PACS-IW with Universal Viewer is a device that displays medical images... | GE Healthcare | LLZ | |
| Z-0170-2016 | Class II | ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment... | Varian Medical Systems, Inc. | MUJ | |
| Z-0124-2016 | Class II | Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes... | Synthes (USA) Products LLC | HRS | |
| Z-0202-2016 | Class III | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040... | Ortho-Clinical Diagnostics, Inc. | JIT | |
| Z-0270-2016 | Class II | Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide... | Howmedica Osteonics Corp | NKB | |
| Z-0438-2016 | Class II | MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed... | Medtronic, Inc. | OYC | |
| Z-0437-2016 | Class II | MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin... | Medtronic, Inc. | OYC | |
| Z-0552-2016 | Class II | Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. | Airways Development, LLC | BYE | |
| Z-0265-2016 | Class II | MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. | Siemens Medical Solutions USA, Inc. | LNS | |
| Z-0340-2016 | Class II | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650... | Siemens Healthcare Diagnostics Inc. | LCP | |
| Z-0162-2016 | Class II | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide... | Materialise N.V. | OSF | |
| Z-0196-2016 | Class II | MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE... | GE Healthcare | LNH | |
| Z-0269-2016 | Class II | Ventilator Tubing | Instrumentation Industries, Incorporated | BTO | |
| Z-0201-2016 | Class II | Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9... | Exactech, Inc. | MEH | |
| Z-0278-2016 | Class II | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length)... | Ethicon Endo-Surgery Inc | LFL | |
| Z-0154-2016 | Class II | TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in... | Berchtold Corp. | FQO | |
| Z-1517-2017 | Class II | Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to... | Merge Healthcare Incorporated | LLZ | |
| Z-1496-2017 | Class II | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is... | Merge Healthcare Incorporated | LLZ | |
| Z-0297-2016 | Class II | Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes... | Roche Diagnostics GmbH | JQP |