510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,476 records, page 936 of 1190
FDA device recalls, page 936 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0202-2010Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent...Zimmer GmbHJWH
Z-0201-2010Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent...Zimmer GmbHJWH
Z-0200-2010Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent...Zimmer GmbHJWH
Z-0199-2010Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent...Zimmer GmbHJWH
Z-1018-2010Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a...Mainline Technology, Inc.LCX
Z-0972-2010Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems...Roche Diagnostics GmbHLCD
Z-0971-2010Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P...Roche Diagnostics GmbHLCD
Z-0970-2010Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and...Roche Diagnostics GmbHLCD
Z-0188-2010XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the...Maquet Cardiovascular Us Sales, LLCFSY
Z-0187-2010XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for...Maquet Cardiovascular Us Sales, LLCFSY
Z-0186-2010XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the...Maquet Cardiovascular Us Sales, LLCFSY
Z-0185-2010HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible...Maquet Cardiovascular Us Sales, LLCFTD
Z-0184-2010HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for...Maquet Cardiovascular Us Sales, LLCFTD
Z-0183-2010HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible illumination for...Maquet Cardiovascular Us Sales, LLCFTD
Z-0182-2010HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for...Maquet Cardiovascular Us Sales, LLCFTD
Z-1956-2010BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517...ZimVie US Corp LLCDZL
Z-1151-2010BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER...Biomet MicrofixationJEY
Z-0592-2010Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE...GE HealthcareLNH
Z-0072-2010Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product...Unomedical A/SBTM
Z-0071-2010Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product...Unomedical A/SBTM
Z-0070-2010Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag...Unomedical A/SBTM
Z-0107-2010Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple...Boston Scientific CorporationDQY
Z-0058-2010Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off...Unomedical A/SBTM
Z-0057-2010Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas...Unomedical A/SBTM
Z-0056-2010Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and...Unomedical A/SBTM
Z-0055-2010Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas...Unomedical A/SBTM
Z-0171-2010Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR...MEDLINE INDUSTRIES, LP - NorthfieldFHW
Z-0054-2010Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off...Unomedical A/SBTM
Z-0053-2010Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E...Unomedical A/SBTM
Z-0052-2010Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and...Unomedical A/SBTM
Z-0051-2010Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and...Unomedical A/SBTM
Z-0050-2010Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel...Unomedical A/SBTM
Z-0049-2010Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow...Unomedical A/SBTM
Z-0048-2010Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow...Unomedical A/SBTM
Z-0047-2010Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow...Unomedical A/SBTM
Z-0046-2010Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name...Unomedical A/SBTM
Z-0045-2010Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No...Unomedical A/SBTM
Z-0044-2010Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product #...Unomedical A/SBTM
Z-0043-2010Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow...Unomedical A/SBTM
Z-0042-2010Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow...Unomedical A/SBTM
Z-0041-2010Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow...Unomedical A/SBTM
Z-0040-2010Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling...Unomedical A/SBTM
Z-0039-2010Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow...Unomedical A/SBTM
Z-0935-2012FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano...Volcano CorporationDQX
Z-1943-2010BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM...Biomet MicrofixationJEY
Z-0263-2010Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF...Stryker Corp.DZI
Z-1819-2011Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System...Philips North America LLCKPS
Z-1251-2011Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial...Elekta LimitedHAW
Z-1007-201110430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain...Siemens Medical Solutions USA, Inc.ITX
Z-1006-201110041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View...Siemens Medical Solutions USA, Inc.IYO