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

59,486 records, page 325 of 1190
FDA device recalls, page 325 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3037-2020Class IIMicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/...Ameditech, Inc.DKC
Z-3036-2020Class IIImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest...Ameditech, Inc.DKC
Z-3035-2020Class IIHenry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry...Ameditech, Inc.LDJ
Z-3034-2020Class IIFastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT...Ameditech, Inc.DIO
Z-3033-2020Class IIConsult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14...Ameditech, Inc.LDJ
Z-3032-2020Class IICLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA...Ameditech, Inc.LDJ
Z-3031-2020Class IIAlere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx...Ameditech, Inc.DIO
Z-3030-2020Class IIAlere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX...Ameditech, Inc.DIO
Z-3029-2020Class IIAlere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/...Ameditech, Inc.DIO
Z-3028-2020Class IIUIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317...Siemens Healthcare Diagnostics Inc.JMO
Z-2999-2020Class IISpeed Stitch Needle CassetteArthroCare CorporationHXK
Z-0057-2021Class IIDual Mobility Vivacit-E Bearing, Model Number 110031009Zimmer GmbHLPH
Z-2998-2020Class IINM/CT 870 DR Model # H3100ASGE HealthcareKPS
Z-2997-2020Class IIDiscovery NM670 Pro Model # H3100XBGE HealthcareKPS
Z-2996-2020Class IIDiscovery 670 DR Model # H3100BTGE HealthcareKPS
Z-2995-2020Class IINM 830 Model # H3910ACGE HealthcareKPS
Z-2994-2020Class IIDiscovery NM 630 Model # H3101RHGE HealthcareKPS
Z-2993-2020Class IINM/CT 870 CZT Model # H3906CWGE HealthcareKPS
Z-2992-2020Class IINm/ct 860, Spect/ctGE HealthcareKPS
Z-2991-2020Class IINM/CT 850 Model Number: H3907ADGE HealthcareKPS
Z-2934-2020Class IISymbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT...Siemens Medical Solutions USA, Inc.KPS
Z-0281-2021Class IISOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate...Sobel WestexOEA
Z-0309-2021Class IICritical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage...Battelle Memorial InstituteQKY
Z-0541-2021Class IIClinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test...Clinical Innovations, LLCNQM
Z-2830-2020Class IIUltra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028...Pharmaceutical Innovations, Inc.MUI
Z-3013-2020Class IICentral Line Dressing Change TrayMEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-3015-2020Class IIStryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to...Stryker MedicalIKY
Z-0009-2021Class IICovidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading...Medtronic, Inc.GDW
Z-0008-2021Class IIEndo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458...Medtronic, Inc.GDW
Z-0007-2021Class IIEndo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo...Medtronic, Inc.GDW
Z-0006-2021Class IIEndo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455...Medtronic, Inc.GDW
Z-0005-2021Class IIEndo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product...Medtronic, Inc.GDW
Z-0004-2021Class IIEndo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453...Medtronic, Inc.GDW
Z-0003-2021Class IIEndo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452...Medtronic, Inc.GDW
Z-0002-2021Class IIEndo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451...Medtronic, Inc.GDW
Z-0001-2021Class IIEndo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code...Medtronic, Inc.GDW
Z-2964-2020Class IIZenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the...Cook IncorporatedMIH
Z-2963-2020Class IILactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended...Randox Laboratories, LimitedCFJ
Z-2962-2020Class IILactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device...Randox Laboratories, LimitedCFJ
Z-2926-2020Class IIThe Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.Exactech, Inc.HSN
Z-3022-2020Class IIRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440Encore Medical, LPPHX
Z-3021-2020Class IIRSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044Encore Medical, LPPHX
Z-2975-2020Class IIAptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot)...Inpeco S.p.A.CEM
Z-2974-2020Class IIAccelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot)...Inpeco S.p.A.CEM
Z-2973-2020Class IIFlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10...Inpeco S.p.A.CEM
Z-2958-2020Class IIWallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370...Boston Scientific CorporationFGE
Z-2968-2020Class IITosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for...Tosoh Bioscience IncJJX
Z-2967-2020Class IITosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number...Tosoh Bioscience IncJIT
Z-2957-2020Class IIIMaquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions...Maquet Cardiovascular Us Sales, LLCKFM
Z-2922-2020Class IIPleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to...Teleflex MedicalGBX