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-1205-2009 | PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC... | Diadexus, Inc. | NOE | ||
| Z-1255-2009 | Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692... | Roche Diagnostics GmbH | LXG | ||
| Z-2193-2011 | Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics... | Digisonics, Inc | LLZ | ||
| Z-2599-2011 | Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product... | Elekta Limited | MUJ | ||
| Z-1790-2010 | Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five... | Alere San Diego, Inc. | jjy | ||
| Z-1789-2010 | Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended... | Alere San Diego, Inc. | jjy | ||
| Z-1788-2010 | Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended... | Alere San Diego, Inc. | jjy | ||
| Z-1803-2009 | Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1802-2009 | Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1801-2009 | Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1800-2009 | Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1799-2009 | Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1798-2009 | Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1797-2009 | Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1796-2009 | Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF... | Medtronic Sofamor Danek USA Inc | MAX | ||
| Z-1173-2009 | Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF... | Medtronic, Inc. | LDF | ||
| Z-3092-2011 | Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco... | Medtronic, Inc. | GEI | ||
| Z-1260-2009 | Remstar Pro M-Series Heated Humidifier System. | Respironics, Inc. | BZD | ||
| Z-1426-2009 | GE Datex-Ohmeda Advance Anesthesia Gas-Machine. | GE Healthcare | BSZ | ||
| Z-0614-2011 | Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model... | Maquet Cardiovascular LLC | GCJ | ||
| Z-1425-2009 | GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine. | GE Healthcare | BSZ | ||
| Z-1553-2009 | Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog... | Cyberkinetics Neurotechnology Systems, Inc. | GZL | ||
| Z-1209-2009 | KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by... | Medtronic, Inc. | HRX | ||
| Z-1198-2009 | Low-Level Output Cable. The device is used to allow the information displayed on the... | Datascope Corp. | DSP | ||
| Z-2339-2010 | Toshiba Aquilion ONE CT SystemTSX-301 A/2D | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1577-2009 | XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A... | Xoran Technologies, LLC | LLZ | ||
| Z-2166-2010 | The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as... | Zoe Medical, Inc. | DXN | ||
| Z-1718-2009 | AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to... | GE Healthcare | KPQ | ||
| Z-1123-2009 | Operon Electrical Operating Room Table. The device is used as an electrical... | Berchtold Corp. | GDC | ||
| Z-0831-2011 | Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is... | Sunrise Medical, Inc. | IOR | ||
| Z-1316-2009 | Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325... | Ethicon, Inc | NEW | ||
| Z-1315-2009 | Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets... | Ethicon, Inc | NEW | ||
| Z-1719-2009 | GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1... | GE Healthcare | DQK | ||
| Z-1222-2009 | ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1221-2009 | ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1220-2009 | 9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1219-2009 | 8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1218-2009 | 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1217-2009 | 8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1216-2009 | 8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1215-2009 | 7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1214-2009 | 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1213-2009 | 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1212-2009 | 8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1211-2009 | 8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1210-2009 | 8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1314-2009 | PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft... | Ethicon, Inc | NEW | ||
| Z-1313-2009 | PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville... | Ethicon, Inc | GAM | ||
| Z-1312-2009 | MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson &... | Ethicon, Inc | GAM | ||
| Z-1311-2009 | MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company... | Ethicon, Inc | GAM |