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-2338-2010 | Unicel DxH 800 Coulter Cellular Analysis System | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2337-2010 | COULTER LH 500 Series System | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1407-2010 | Product is a pull cord type monitor, bed patient alarm used to detect patient/resident... | Alimed, LLC | KMI | ||
| Z-2501-2010 | UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the... | Abbott Diagnostics Scarborough, Inc. | LCX | ||
| Z-2500-2010 | UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG... | Abbott Diagnostics Scarborough, Inc. | LCX | ||
| Z-2419-2010 | Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JFY | ||
| Z-1783-2010 | Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation... | Nova Biomedical Corporation | CGA | ||
| Z-1403-2010 | GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions... | GE Healthcare | LLZ | ||
| Z-1402-2010 | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL... | GE Healthcare | LLZ | ||
| Z-1440-2010 | Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead... | Medtronic, Inc. | DXY | ||
| Z-1197-2010 | Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa... | Baxter Corporation Englewood | LHI | ||
| Z-0846-2011 | The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device... | Neusoft Medical Systems Co., Ltd. | JAK | ||
| Z-1747-2010 | GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and... | GE Healthcare | LLZ | ||
| Z-1311-2010 | Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for... | KaVo Dental Technologies, LLC | KLC | ||
| Z-1551-2010 | Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149... | Leica Microsystems, Inc. | IEO | ||
| Z-1229-2011 | AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and... | American Medical Systems Innovation Center - Silicon Valley | GEX | ||
| Z-1254-2010 | Qwix 4.3mm Stabilization Screws - 34mm | Integra LifeSciences Corporation | HWC | ||
| Z-1592-2010 | Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204... | Galt Medical Corp | DRE | ||
| Z-1163-2010 | Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used... | OLYMPUS Corporation of the Americas | KOG | ||
| Z-1253-2010 | Qwix 4.3mm Stabilization Screws - 32mm | Integra LifeSciences Corporation | HWC | ||
| Z-1157-2010 | Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in... | Medtronic, Inc. | GDW | ||
| Z-0816-2010 | Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada... | Baylis Medical Co., Inc. | DYB | ||
| Z-1318-2010 | Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1458-2011 | The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R... | Philips North America LLC | LNH | ||
| Z-1217-2010 | Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes... | Ulti Med, Inc. | FMF | ||
| Z-1798-2010 | i-STAT E3+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1797-2010 | i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1796-2010 | i-STAT 6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1795-2010 | i-STAT EC8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1794-2010 | i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1793-2010 | i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1792-2010 | i-STAT CG8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1791-2010 | i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro... | Abbott Medical | JPI | ||
| Z-1176-2010 | Image Consultant (IC) Software | Gulden Ophthalmics | NFF | ||
| Z-2386-2010 | ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent... | Roche Diagnostics GmbH | LAN | ||
| Z-2449-2010 | BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris... | Philips North America LLC | IZI | ||
| Z-2448-2010 | MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20... | Philips North America LLC | IZI | ||
| Z-1658-2010 | Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1657-2010 | Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1227-2010 | CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is... | K C Pharmaceuticals Inc | LYL | ||
| Z-1226-2010 | Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product... | K C Pharmaceuticals Inc | LYL | ||
| Z-1225-2010 | Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297. This... | K C Pharmaceuticals Inc | LYL | ||
| Z-1224-2010 | Safeway Sterile Preserved Saline Solution 12oz, Product SKU#321130-700707. This... | K C Pharmaceuticals Inc | LYL | ||
| Z-1223-2010 | Top Care Sterile Preserved Saline Solution 12oz, Product SKU#0036800-16040. This... | K C Pharmaceuticals Inc | LYL | ||
| Z-1222-2010 | Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767. This product... | K C Pharmaceuticals Inc | LYL | ||
| Z-1249-2010 | Cardiovive 92532 automated external defibrillator. This semi-automatic model requires... | ZOLL Medical Corporation | MKJ | ||
| Z-1248-2010 | Responder 2023440 automated external defibrillator. This semi-automatic model requires... | ZOLL Medical Corporation | MKJ | ||
| Z-1247-2010 | Powerheart 9390E automated external defibrillator. This semi-automatic model requires... | ZOLL Medical Corporation | MKJ | ||
| Z-1246-2010 | Powerheart 9390A automated external defibrillator. This fully automatic model does not... | ZOLL Medical Corporation | MKJ | ||
| Z-1245-2010 | Powerheart 9300P automated external defibrillator. This semi-automatic model requires... | ZOLL Medical Corporation | MKJ |