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-0757-2012 | 1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP... | Integra Pain Management | HBG | ||
| Z-0756-2012 | 31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF... | Integra Pain Management | HBG | ||
| Z-0755-2012 | 31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial... | Integra Pain Management | HBG | ||
| Z-0754-2012 | 1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck... | Integra Pain Management | HBG | ||
| Z-0753-2012 | Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile... | Integra Pain Management | HBG | ||
| Z-0752-2012 | Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and... | Integra Pain Management | HBG | ||
| Z-0751-2012 | Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and... | Integra Pain Management | HBG | ||
| Z-0750-2012 | Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and... | Integra Pain Management | HBG | ||
| Z-0749-2012 | Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and... | Integra Pain Management | HBG | ||
| Z-0748-2012 | 1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain... | Integra Pain Management | HBG | ||
| Z-1318-2013 | Class II | GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131... | GE Healthcare | OWB | |
| Z-0115-2013 | Class II | GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for... | GE Healthcare | IZI | |
| Z-0114-2013 | Class II | GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for... | GE Healthcare | IZI | |
| Z-0113-2013 | Class II | GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for... | GE Healthcare | IZI | |
| Z-0815-2012 | Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt... | Mallinckrodt, Inc. | DXT | ||
| Z-0746-2012 | DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by... | Eastman Kodak Company | IWZ | ||
| Z-1089-2015 | Class II | Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable... | Highridge Medical, LLC | NKB | |
| Z-2281-2012 | Class II | The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable... | Abbott Medical | LGW | |
| Z-2280-2012 | Class II | Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4... | Abbott Medical | LGW | |
| Z-1983-2012 | Class II | Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid... | Abbott Medical | LGW | |
| Z-1043-2012 | Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and... | Siemens Healthcare Diagnostics Inc. | GGW | ||
| Z-1096-2012 | LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for... | Boston Scientific Corporation | LWS | ||
| Z-0821-2012 | NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St... | Boston Scientific Corporation | OEZ | ||
| Z-0740-2012 | U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup... | Ortho Development Corp. | LZO | ||
| Z-0922-2012 | MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR... | Porex Surgical, Inc. | FTM | ||
| Z-1008-2012 | S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj... | Radiometer America, Inc | CGL | ||
| Z-1061-2012 | ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of... | Geomed Medizin-Technik GmbH & Co. KG | GWG | ||
| Z-0694-2012 | MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20... | Merz North America, Inc. | FMI | ||
| Z-0713-2012 | Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA... | Varian Medical Systems, Inc. | IYE | ||
| Z-0737-2012 | NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended... | Medtronic, Inc. | OUG | ||
| Z-0110-2013 | Class III | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-1067-2012 | GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when... | GE Healthcare | LNH | ||
| Z-0972-2012 | Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic... | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-1071-2012 | Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy... | Zimmer GmbH | JDC | ||
| Z-0826-2012 | NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with... | NxStage Medical Inc | FKR | ||
| Z-0637-2012 | ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac... | Microgenics Corporation | JJY | ||
| Z-1081-2012 | LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC... | Greiner Bio-One North America, Inc. | JKA | ||
| Z-0814-2012 | Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model... | Medtronic, Inc. | DWE | ||
| Z-0813-2012 | Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide... | Medtronic, Inc. | DTZ | ||
| Z-0812-2012 | Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula... | Medtronic, Inc. | DWF | ||
| Z-0811-2012 | Medtronic, DLP, DLP Malleable Single Stage Venous CannulaeRx Only, Sterilized Using... | Medtronic, Inc. | DWF | ||
| Z-0810-2012 | Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using... | Medtronic, Inc. | DWF | ||
| Z-0809-2012 | Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO... | Medtronic, Inc. | DWF | ||
| Z-0808-2012 | Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic... | Medtronic, Inc. | DWF | ||
| Z-0807-2012 | Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only... | Medtronic, Inc. | DWF | ||
| Z-2226-2012 | Class II | UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker... | Siemens Healthcare Diagnostics Inc. | KPA | |
| Z-2225-2012 | Class II | UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer... | Siemens Healthcare Diagnostics Inc. | CKG | |
| Z-1056-2012 | TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model... | Philips North America LLC | KPS | ||
| Z-0946-2012 | Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed... | Philips North America LLC | JAK | ||
| Z-1476-2012 | Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is... | Securitas Healthcare LLC | KMI |