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 377 of 1190
FDA device recalls, page 377 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0349-2020Class IIMODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial...Synthes (USA) Products LLCN/A
Z-0368-2020Class IILemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to...Mavidon Medical ProdKOY
Z-0029-2020Class IIIEmbryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, &...CooperSurgical, Inc.MQG
Z-1373-2021Class IIMicroScan WalkAway-96 plus Reconditioned InstrumentSiemens Healthcare Diagnostics Inc.LRG
Z-1372-2021Class IIMicroScan WalkAway-40 plus Reconditioned InstrumentSiemens Healthcare Diagnostics Inc.LRG
Z-1371-2021Class IIMicroScan WalkAway-96 plus InstrumentSiemens Healthcare Diagnostics Inc.LRG
Z-1370-2021Class IIMicroScan WalkAway-40 plus InstrumentSiemens Healthcare Diagnostics Inc.LRG
Z-1752-2020Class IIOpiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800...Siemens Healthcare Diagnostics Inc.DJG
Z-1751-2020Class IISynchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in...Siemens Healthcare Diagnostics Inc.DJG
Z-0345-2020Class IIlmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump...Abiomed, Inc.OZD
Z-2561-2019Class IIMonaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The...Elekta LimitedMUJ
Z-2560-2019Class IIMonaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The...Elekta LimitedMUJ
Z-0113-2020Class IIAchilles Express Bone SonometerGE HealthcareMUA
Z-0112-2020Class IIAchilles Insight Bone SonometerGE HealthcareMUA
Z-0123-2020Class IISolarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X...Medtronic IrelandLOX
Z-0122-2020Class IIEuphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X...Medtronic IrelandLOX
Z-2261-2020Class IIXhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians...GE HealthcareMHX
Z-1844-2020Class IITransducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33...Philips North America LLCITX
Z-1843-2020Class IITransducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with...Philips North America LLCITX
Z-1842-2020Class IITransducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33...Philips North America LLCITX
Z-1841-2020Class IITransducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ...Philips North America LLCITX
Z-0175-2020Class IIApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry...GE HealthcareDSI
Z-0234-2020Class IISPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/...Pajunk GmbH MedizintechnologieBSP
Z-0260-2020Class IIDario Blood Glucose Monitoring System, Model No. 1015-05, running Android software...Labstyle Innovations, Ltd.NBW
Z-1693-2020Class IINavLock Tracker *** Rx OnlyMedtronic Navigation, IncOLO
Z-1851-2020Class IINobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965...Nobel Biocare USA LLCDZE
Z-1336-2020Class II1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429Ethicon, IncNEW
Z-1335-2020Class II1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402Ethicon, IncNEW
Z-1334-2020Class II1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201Ethicon, IncNEW
Z-0121-2020Class IICenturion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the...Centurion Medical Products, LPHFX
Z-0120-2020Class IICenturion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the...Centurion Medical Products, LPHFX
Z-0109-2020Class IIcobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog...Roche Diagnostics GmbHDDG
Z-0108-2020Class IIcobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference...Roche Diagnostics GmbHDDG
Z-1532-2020Class IIKarl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1Karl Storz Endoscopy-America, Inc.GWG
Z-1531-2020Class IIKarl Storz, Model # 11161C2, Flexible NeuroscopeKarl Storz Endoscopy-America, Inc.GWG
Z-1530-2020Class IIKarl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric NeuroscopeKarl Storz Endoscopy-America, Inc.GWG
Z-0697-2020Class IILow Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage...NxStage Medical IncPEV
Z-2544-2019Class IIAD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b)...AD-Tech Medical Instrument Corp.HBG
Z-2440-2020Class IIControl Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2...LivaNova Deutschland GmbHDWA
Z-2439-2020Class IIControl Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2...LivaNova Deutschland GmbHDWA
Z-1708-2020Class IIPositron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-1631-2020Class IIPharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser...Ra Medical Systems,IncGEX
Z-2547-2019Class IIIntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is...Philips North America LLCMHX
Z-2409-2019Class IIMonaco Radiation Treatment Planning System (RTP) SystemElekta LimitedMUJ
Z-1452-2020Class IIConcerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083)...ArjoHuntleigh Polska Sp. zo.o.FSA
Z-0221-2020Class ICentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model...Thoratec Switzerland GmbHKFM
Z-0561-2020Class IVNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve...LivaNova USA, Inc.LYJ
Z-0064-2020Class IIiTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific...ConforMIS, Inc.LPH
Z-0063-2020Class IIiTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific...ConforMIS, Inc.LPH
Z-2559-2019Class IIThe HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour...Getinge US Sales LLCMAL