510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 56 of 1190
FDA device recalls, page 56 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0421-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC...Mozarc Medical US LLCNIE
Z-0502-2026Class IIMultichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive...Techno-Path Manufacturing Ltd.OHQ
Z-0501-2026Class IIMultichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive...Techno-Path Manufacturing Ltd.OHQ
Z-0572-2026Class IIBrand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name...OLYMPUS Corporation of the AmericasLJE
Z-0582-2026Class IIEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;Straumann USA, LLCNQA
Z-0430-2026Class IBD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF...CareFusion 303, IncFRN
Z-0327-2026Class IIVANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.Canon Medical Systems USA, Inc.LNH
Z-0499-2026Class IICeiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed...Shimadzu Corporation Medical Systems DivisionIYB
Z-0997-2026Class IIBECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system...Beckman Coulter Ireland IncKHS
Z-0504-2026Class IIBD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;Becton Dickinson & CoKYW
Z-0579-2026Class IIBrand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus...OLYMPUS Corporation of the AmericasFDT
Z-1436-2026Class IIMRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved...MRIMed Inc. dba: Quality Safety ToolsKZF
Z-0871-2026Class IIPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SParagon 28HSB
Z-0583-2026Class IIDermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided...Dermasensor IncQZS
Z-0488-2026Class ITMJ Bilateral Implant REF: CHG020 Sterile EO, Rx OnlyTMJ Solutions, LLCLZD
Z-0451-2026Class IConvenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0450-2026Class IConvenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATEMEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0449-2026Class IAnesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230MEDLINE INDUSTRIES, LP - NorthfieldCAH
Z-0448-2026Class IConvenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0447-2026Class IConvenience Kit, BREAST HERNIA DYNJ909125GMEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0446-2026Class IDynj909119g Robotic Gastric Lap Sleeve-Lf Dynj909127f Cysto Dynj909129d General...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0445-2026Class IAnesthesia Circuit Kits and other various kits that contain Anesthesia...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-0444-2026Class IAnesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0443-2026Class IAnesthesia Circuit Kits and other various kits that contain Anesthesia...MEDLINE INDUSTRIES, LP - NorthfieldOFQ
Z-0442-2026Class IAnesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1099-2026Class IICentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE...Abbott MedicalQNR
Z-0956-2026Class IIMyosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF...Myofunctional Research Co. USALRK
Z-0532-2026Class ISJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH...Glycar SA Pty., Ltd.DXZ
Z-0531-2026Class ISJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH...Glycar SA Pty., Ltd.DXZ
Z-1092-2026Class IIBrand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026...C-Rad Positioning ABIYE
Z-0588-2026Class IIQuantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage tablePivotal Health SolutionsISA
Z-0587-2026Class IIQuantum Intersegmental Table, Model/Catalog Number: Q400; heated massage tablePivotal Health SolutionsISA
Z-0440-2026Class IIbk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler...BK Medical ApSIYN
Z-0439-2026Class IIbk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler...BK Medical ApSIYN
Z-0438-2026Class IIbk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler...BK Medical ApSIYN
Z-0437-2026Class IIUUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed...BK Medical ApSIYN
Z-0436-2026Class IIUltrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System...BK Medical ApSIYN
Z-0435-2026Class II1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus...BK Medical ApSIYN
Z-0508-2026Class IIBrand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog...Abbott MedicalDSQ
Z-0507-2026Class IIBrand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number...Abbott MedicalDSQ
Z-0506-2026Class IIBrand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog...Abbott MedicalDSQ
Z-0505-2026Class IIBrand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS)...Abbott MedicalDSQ
Z-0542-2026Class IIREF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in...Cellavision ABJOY
Z-0574-2026Class IIBrand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV...Sterilmed IncOWQ
Z-0573-2026Class IIBrand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS...Sterilmed IncOWQ
Z-0452-2026Class IIBrand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy...OLYMPUS Corporation of the AmericasFEO
Z-0569-2026Class IIMeridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid...Meridian Bioscience IncNJR
Z-0568-2026Class IIMeridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid...Meridian Bioscience IncOMN
Z-0413-2026Class IIGood Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog...Trividia Health, Inc.NBW
Z-0481-2026Class IISimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits...Respironics, Inc.CAW