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-2474-2010 | Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara... | Philips North America LLC | IZI | ||
| Z-2473-2010 | Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can... | Philips North America LLC | IZI | ||
| Z-2472-2010 | Philips Integris H5000F Angiographic X-ray system. This system with Velara Generator can... | Philips North America LLC | IZI | ||
| Z-2471-2010 | Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator... | Philips North America LLC | IZI | ||
| Z-0593-2009 | Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing... | FUJIFILM Biosciences Inc. | MQE | ||
| Z-0854-2009 | Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog... | Integra LifeSciences Corporation | LXH | ||
| Z-0414-2009 | Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0817-2009 | Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors... | Philips North America LLC | DSI | ||
| Z-2482-2010 | ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott... | Abbott Medical | JJE | ||
| Z-1704-2010 | Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic... | Intelligent Hearing Systems Corp. | GWJ | ||
| Z-0883-2009 | Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit... | ZOLL Manufacturing Corporation | MVK | ||
| Z-0835-2009 | Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. Sterile... | Tournier, Inc. | KWS | ||
| Z-0834-2009 | Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile... | Tournier, Inc. | KWS | ||
| Z-0833-2009 | Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054. Sterile... | Tournier, Inc. | KWS | ||
| Z-0832-2009 | Tornier AFFINITI Humeral Head Standard 52mm x 18mm, Catalog No. 0020053. Sterile... | Tournier, Inc. | KWS | ||
| Z-0831-2009 | Tornier AFFINITI Humeral Head Standard 52mm x 15mm, Catalog No. 0020052. Sterile... | Tournier, Inc. | KWS | ||
| Z-0830-2009 | Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile... | Tournier, Inc. | KWS | ||
| Z-0829-2009 | Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile... | Tournier, Inc. | KWS | ||
| Z-0828-2009 | Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile... | Tournier, Inc. | KWS | ||
| Z-0827-2009 | Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile... | Tournier, Inc. | KWS | ||
| Z-0826-2009 | Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile... | Tournier, Inc. | KWS | ||
| Z-0825-2009 | Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile... | Tournier, Inc. | KWS | ||
| Z-0824-2009 | Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile... | Tournier, Inc. | KWS | ||
| Z-0823-2009 | Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile... | Tournier, Inc. | KWS | ||
| Z-0822-2009 | Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile... | Tournier, Inc. | KWS | ||
| Z-0821-2009 | Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile... | Tournier, Inc. | KWS | ||
| Z-0820-2009 | Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile... | Tournier, Inc. | KWS | ||
| Z-0819-2009 | Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile... | Tournier, Inc. | KWS | ||
| Z-0818-2009 | Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile... | Tournier, Inc. | KWS | ||
| Z-0502-2009 | STA Neoplastine CI Plus 10; Product Catalogue Number: 0667 Manufactured by Diagnostica... | Diagnostica Stago, Inc. | GJS | ||
| Z-0501-2009 | STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago... | Diagnostica Stago, Inc. | GJS | ||
| Z-0499-2009 | FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc... | FHC, Inc. | GZL | ||
| Z-0498-2009 | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by... | FHC, Inc. | GZL | ||
| Z-0497-2009 | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative... | FHC, Inc. | GZL | ||
| Z-0323-2009 | Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a... | Arjo, Inc. | FSA | ||
| Z-0322-2009 | Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient... | Arjo, Inc. | FSA | ||
| Z-2270-2010 | Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product... | GE Healthcare | DQK | ||
| Z-1041-2009 | Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0975-2009 | Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A... | Medtronic, Inc. | DTZ | ||
| Z-0495-2009 | Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0494-2009 | Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0493-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0492-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0491-2009 | Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0490-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0489-2009 | Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0488-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0487-2009 | Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston... | Boston Scientific Corporation | FCG | ||
| Z-0340-2009 | STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and... | Advanced Sterilization Products | MLR | ||
| Z-0641-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF |