510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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

59,486 records, page 833 of 1190
FDA device recalls, page 833 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3040-2011enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model...Vital Signs, Inc.LGZ
Z-3042-2011Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL)...Bausch & Lomb IncorporatedLYL
Z-3002-2011Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage...Varian Medical Systems, Inc.MUJ
Z-2944-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2943-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2942-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2941-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2940-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 16 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2939-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2938-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2937-2011RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm, Distributed by...Teleflex MedicalKOD
Z-2936-2011RUSCH, GB: Female Catheter, All Purpose PVC, 16 Fr. 18 cm, Distributed by Teleflex...Teleflex MedicalKOD
Z-2935-2011RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex...Teleflex MedicalKOD
Z-2934-2011RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm, Distributed by Teleflex...Teleflex MedicalKOD
Z-2933-2011RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Distributed by Teleflex...Teleflex MedicalKOD
Z-2932-2011RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex...Teleflex MedicalKOD
Z-2983-2011LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi...Siemens Medical Solutions USA, Inc.LMB
Z-3265-2011Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency...ZOLL Medical CorporationMKJ
Z-3177-2011Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with...C P Medical Inc.GAR
Z-2957-2011HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile...Greiner Bio-One North America, Inc.FMI
Z-2917-2011Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN...ZOLL Medical CorporationMKJ
Z-3009-2011Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray systemSiemens Medical Solutions USA, Inc.IZL
Z-2034-2012Class IIepoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis...Epocal IncCGA
Z-3099-2011PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement...Depuy Orthopaedics Inc.JWH
Z-2883-2011Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining...Arrow International LLC (subsidiary of Teleflex Incorporated)MSD
Z-3011-2011Stryker EMS Stair - Pro Evacuation Chair Model 6252 It Is intended to aid in the...Stryker MedicalFPP
Z-3010-2011Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of...Stryker MedicalFPP
Z-2878-2011ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA...Medtronic Sofamor Danek USA IncKWP
Z-2877-2011VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800...Medtronic Sofamor Danek USA IncKWP
Z-2876-2011CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic...Medtronic Sofamor Danek USA IncNKB
Z-2875-2011CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor...Medtronic Sofamor Danek USA IncKWP
Z-2874-2011CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor...Medtronic Sofamor Danek USA IncKWP
Z-0921-2012Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number...Catch IncorporatedLPS
Z-0270-2012"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model...Uplift Technologies Inc.INN
Z-3100-2011Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation...Varian Medical Systems, Inc.IYE
Z-3106-2011Depuy Mitek Ratchet Handle with Quick Connect Product code: 219970. Instrument used...DePuy Mitek, Inc.LXH
Z-2831-2011Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex...Teleflex MedicalNNY
Z-1659-2013Class II***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN...The Anspach Effort, Inc.NAV
Z-1658-2013Class II***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN...The Anspach Effort, Inc.NAV
Z-1657-2013Class II***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the...The Anspach Effort, Inc.NAV
Z-0175-2012Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot...Howmedica Osteonics CorpHSB
Z-1117-2012VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR...Ortho-Clinical Diagnostics, Inc.DLZ
Z-0307-2012Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed...Elekta LimitedIWB
Z-0187-2012Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers...Invacare GmbHLLI
Z-3082-2011Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented...TORNIER Inc.JDB
Z-3098-2011Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2...Varian Medical Systems, Inc.IYE
Z-1195-2012ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline...Siemens Healthcare Diagnostics Inc.CIN
Z-0920-2012The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound...Novomedicus LLCFTL
Z-0919-2012The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only...Novomedicus LLCFTL
Z-0013-2012Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57...ConvaTec LimitedEXB