Medical Device
Manufacturing
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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 954 of 1190
FDA device recalls, page 954 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1005-2010Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc...Whatman, Inc.JKA
Z-1569-2009Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX...STRYKER Communications, Inc.BRY
Z-1528-2009Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet...Zimmer GmbHKRO
Z-1527-2009Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet...Zimmer GmbHKRO
Z-1526-2009Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet...Zimmer GmbHKRO
Z-1939-2009The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive...Verathon Inc.IYO
Z-0904-2011VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical...Carl Zeiss Meditec IncEPT
Z-1519-2009Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber...Medtronic, Inc.NVZ
Z-1518-2009Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for...Medtronic, Inc.DXY
Z-1517-2009Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing...Medtronic, Inc.DXY
Z-1516-2009Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models...Medtronic, Inc.DXY
Z-1515-2009Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate...Medtronic, Inc.NVZ
Z-1514-2009Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303.Medtronic, Inc.DXY
Z-1513-2009Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber...Medtronic, Inc.NVZ
Z-1512-2009Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models...Medtronic, Inc.DXY
Z-1511-2009Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Single Chamber...Medtronic, Inc.NVZ
Z-1510-2009Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106...Medtronic, Inc.DXY
Z-2118-2011ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical...Siemens Medical Solutions USA, Inc.IYN
Z-2117-2011ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens...Siemens Medical Solutions USA, Inc.IYN
Z-2116-2011ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by...Siemens Medical Solutions USA, Inc.IYN
Z-2115-2011ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by...Siemens Medical Solutions USA, Inc.IYN
Z-2038-2009First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually...Allied Medical LLCECX
Z-2037-2009Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product...Allied Medical LLCECX
Z-2036-2009Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as...Allied Medical LLCECX
Z-2035-2009Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as...Allied Medical LLCECX
Z-2034-2009Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product...Allied Medical LLCECX
Z-2033-2009Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product...Allied Medical LLCECX
Z-2032-2009Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product...Allied Medical LLCECX
Z-2031-2009Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container)...Allied Medical LLCECX
Z-1891-2010IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine...Siemens Healthcare Diagnostics Inc.JJE
Z-1619-2009Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; Howmedica Osteonics...Howmedica Osteonics CorpJWH
Z-1618-2009Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics...Howmedica Osteonics CorpJWH
Z-1615-2009Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression...Zimmer GmbHLWJ
Z-1716-2009CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length...Wright Medical Technology IncJDL
Z-1715-2009CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length...Wright Medical Technology IncJDL
Z-1868-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in...Stryker Corp.MEB
Z-1867-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL...Stryker Corp.MEB
Z-1866-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL...Stryker Corp.MEB
Z-1865-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL...Stryker Corp.MEB
Z-1864-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL...Stryker Corp.MEB
Z-1863-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, sterile...Stryker Corp.MEB
Z-1862-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 5.0...Stryker Corp.MEB
Z-1861-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 10.0...Stryker Corp.MEB
Z-1860-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, sterile...Stryker Corp.MEB
Z-1859-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL...Stryker Corp.MEB
Z-1858-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL...Stryker Corp.MEB
Z-1857-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL...Stryker Corp.MEB
Z-1856-2009Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL...Stryker Corp.MEB
Z-1855-2009Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters...Stryker Corp.MEB
Z-1854-2009Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters...Stryker Corp.MEB