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-1219-2008 | INTELECT LEGEND XT, Model No. 2763, Chattanooga Group, Hixson, TN 37343, Made in the USA | Chattanooga Corp Inc | MPH | ||
| Z-1218-2008 | INTELECT INTELECT XT, Model No. 2760, Chattanooga Group, Hixson, TN 37343, Made in the... | Chattanooga Corp Inc | MPH | ||
| Z-0982-2008 | VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) | ZOLL Palm Springs | CBK | ||
| Z-1647-2012 | EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional... | Biosense Webster Inc | DRF | ||
| Z-0368-2008 | GE Healthcare OEC 9900 mobile fluoroscopic x-ray system | GE Healthcare | JAA | ||
| Z-1891-2008 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as... | GE Healthcare | LNH | ||
| Z-1890-2008 | GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device... | GE Healthcare | LNH | ||
| Z-1117-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-0879-2008 | Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer... | Abbott Medical | FPA | ||
| Z-0878-2008 | Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml... | Abbott Medical | FRN | ||
| Z-0877-2008 | Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder... | Abbott Medical | FRN | ||
| Z-0876-2008 | Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder... | Abbott Medical | FRN | ||
| Z-1116-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1115-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1114-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1113-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1112-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1111-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-1110-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of... | Horiba Instruments Incorporated | CKA | ||
| Z-2422-2010 | DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State... | Philips North America LLC | KPR | ||
| Z-1660-2008 | LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use... | LifeSync Corporation | DRG | ||
| Z-1659-2008 | LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for... | LifeSync Corporation | DRG | ||
| Z-1139-2008 | AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051 | Visx Incorporated, a Subsidiary of AMO Inc | LZS | ||
| Z-1447-2008 | Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging... | Given Imaging Ltd. | NEZ | ||
| Z-1161-2008 | S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and... | GE Healthcare | MSX | ||
| Z-0707-2008 | Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581 | Zimmer GmbH | JWH | ||
| Z-0706-2008 | Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581 | Zimmer GmbH | JWH | ||
| Z-1698-2008 | Urethral Warming System-Galil Medical Warming Catheter. The product is contained within... | Galil Medical Ltd. | GEH | ||
| Z-1306-2008 | IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The... | AGFA Healthcare Corp. | LMD | ||
| Z-0841-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0840-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0839-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0838-2008 | B. Braun, Heparin Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-3005-02... | Am2 Pat, Inc. | FOZ | ||
| Z-0837-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0836-2008 | B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL... | Am2 Pat, Inc. | FOZ | ||
| Z-0835-2008 | B. Braun, Normal Saline IV Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a 12mL... | Am2 Pat, Inc. | FOZ | ||
| Z-0834-2008 | B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL... | Am2 Pat, Inc. | FOZ | ||
| Z-0833-2008 | Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL... | Am2 Pat, Inc. | FOZ | ||
| Z-0832-2008 | Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill... | Am2 Pat, Inc. | FOZ | ||
| Z-0831-2008 | Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill... | Am2 Pat, Inc. | FOZ | ||
| Z-0830-2008 | B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0829-2008 | B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC... | Am2 Pat, Inc. | FOZ | ||
| Z-0828-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride... | Am2 Pat, Inc. | FOZ | ||
| Z-0827-2008 | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride... | Am2 Pat, Inc. | FOZ | ||
| Z-1763-2008 | Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1762-2008 | Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1761-2008 | Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1760-2008 | Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1759-2008 | Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1758-2008 | Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator, part... | Siemens Medical Solutions USA, Inc. | IYE |