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-0690-2012 | Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for... | GE Healthcare | DSI | ||
| Z-0393-2012 | Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18... | Kimberly-Clark Corporation | HEB | ||
| Z-0264-2012 | Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO... | Boston Scientific Corporation | DRE | ||
| Z-0351-2012 | The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted... | Bard Peripheral Vascular Inc | FCK | ||
| Z-1193-2012 | PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro... | Pointcare Technologies, Inc. | GKZ | ||
| Z-0462-2012 | syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0676-2012 | Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic... | Synthes GmbH | HTW | ||
| Z-0417-2012 | OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint... | Zimmer GmbH | KRO | ||
| Z-0867-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including... | GUNNELL, Inc. | IOR | ||
| Z-0866-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including... | GUNNELL, Inc. | IOR | ||
| Z-0865-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including... | GUNNELL, Inc. | IOR | ||
| Z-0864-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including... | GUNNELL, Inc. | IOR | ||
| Z-0863-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including... | GUNNELL, Inc. | IOR | ||
| Z-0313-2012 | Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use... | Philips North America LLC | MQB | ||
| Z-0646-2012 | Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0645-2012 | Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R)... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0644-2012 | Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0370-2012 | Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build... | Varian Medical Systems, Inc. | MUJ | ||
| Z-0943-2012 | Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE... | Stryker Medical | FPP | ||
| Z-0364-2012 | TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended... | Varian Medical Systems, Inc. | -IYE | ||
| Z-0318-2012 | DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is... | DePuy Mitek, Inc. | MAI | ||
| Z-0317-2012 | DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor... | DePuy Mitek, Inc. | MAI | ||
| Z-0316-2012 | DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor... | DePuy Mitek, Inc. | MAI | ||
| Z-0315-2012 | DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor... | DePuy Mitek, Inc. | MAI | ||
| Z-0314-2012 | DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System... | DePuy Mitek, Inc. | MAI | ||
| Z-0281-2012 | Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor... | Draeger, Inc. | MHX | ||
| Z-0294-2017 | Class II | Fusion Workstation.; Indicated for the transmission and review of radiological images. | Merge Healthcare Incorporated | LLZ | |
| Z-0159-2013 | Class II | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder... | Progressive Medical Inc | GDI | |
| Z-0265-2013 | Class II | 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to... | Shimadzu Medical Systems | IZL | |
| Z-0264-2013 | Class II | 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take... | Shimadzu Medical Systems | IZL | |
| Z-0263-2013 | Class II | 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt... | Shimadzu Medical Systems | IZL | |
| Z-0262-2013 | Class II | 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt... | Shimadzu Medical Systems | IZL | |
| Z-0261-2013 | Class II | R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray... | Shimadzu Medical Systems | IZX | |
| Z-0260-2013 | Class II | R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray... | Shimadzu Medical Systems | IZW | |
| Z-1160-2012 | Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The... | OLYMPUS Corporation of the Americas | FEM | ||
| Z-1677-2012 | Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics... | Howmedica Osteonics Corp | MEH | ||
| Z-0971-2012 | VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name... | Ortho-Clinical Diagnostics, Inc. | JIT | ||
| Z-0970-2012 | Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number... | Gentherm Medical, LLC | DWJ | ||
| Z-0969-2012 | Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R... | Gentherm Medical, LLC | DWJ | ||
| Z-1504-2012 | Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. | Terumo BCT, Ltd | LKN | ||
| Z-0274-2012 | Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0310-2012 | cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of... | Roche Diagnostics GmbH | JJE | ||
| Z-0349-2012 | Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in... | Encore Medical, LP | JWH | ||
| Z-1065-2012 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution... | GE Healthcare | KPR | ||
| Z-0362-2012 | SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a... | SCC Soft Computer | LNX | ||
| Z-0710-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw... | Cerenovus, Inc. | GWM | ||
| Z-0709-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw... | Cerenovus, Inc. | GWM | ||
| Z-0708-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid... | Cerenovus, Inc. | GWM | ||
| Z-0707-2012 | Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product... | Cerenovus, Inc. | GWM | ||
| Z-0706-2012 | Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The... | Cerenovus, Inc. | GWM |