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 358 of 1190
FDA device recalls, page 358 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1376-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1375-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1374-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1373-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1372-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1371-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1370-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1369-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1368-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1367-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1366-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1365-2020Class IINUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376...BIOMERIEUX SA - GrenoblePPM
Z-1111-2020Class IITerumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product...Terumo Cardiovascular Systems CorporationDTQ
Z-1110-2020Class IITerumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is...Terumo Cardiovascular Systems CorporationDTQ
Z-1109-2020Class IITerumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product...Terumo Cardiovascular Systems CorporationDTQ
Z-1108-2020Class IITerumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product...Terumo Cardiovascular Systems CorporationDTQ
Z-1117-2020Class IIRusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemTeleflex MedicalCCW
Z-1116-2020Class IIRusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemTeleflex MedicalCCW
Z-2758-2020Class IISIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model...Siemens Medical Solutions USA, Inc.KPR
Z-2757-2020Class IISIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device...Siemens Medical Solutions USA, Inc.JAA
Z-2756-2020Class IISIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device...Siemens Medical Solutions USA, Inc.JAA
Z-2755-2020Class IISIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device...Siemens Medical Solutions USA, Inc.JAA
Z-1339-2020Class IIYsio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used...Siemens Medical Solutions USA, Inc.KPR
Z-1338-2020Class IILuminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device...Siemens Medical Solutions USA, Inc.OWB
Z-1337-2020Class IILuminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended...Siemens Medical Solutions USA, Inc.OWB
Z-1333-2020Class IIUroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device...Siemens Medical Solutions USA, Inc.OWB
Z-1332-2020Class IILuminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device...Siemens Medical Solutions USA, Inc.OWB
Z-1331-2020Class IILuminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended...Siemens Medical Solutions USA, Inc.OWB
Z-1477-2020Class IICordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020SCordis US Corp.LIT
Z-1926-2020Class IISpy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI...Stryker Corp.MMP
Z-1925-2020Class IISpy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI...Stryker Corp.MMP
Z-1474-2020Class ICME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG...CME America, LLCFRN
Z-1347-2020Class IITHP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451...Zimmer GmbHJDO
Z-1158-2020Class IIcobas infinity core, Material No. 7154003001. The device is a calculator/data processing...Roche Diagnostics GmbHJQP
Z-1716-2020Class IIPortex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and...Abbott MedicalJKA
Z-1715-2020Class IIPortex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and...Abbott MedicalJKA
Z-0865-2020Class IIMedline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-0842-2020Class IIInstrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Palodex Group OyMQB
Z-0841-2020Class IIKaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Palodex Group OyMQB
Z-0840-2020Class IIGendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Palodex Group OyMQB
Z-0839-2020Class IISoredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Palodex Group OyMQB
Z-0987-2020Class IICocoon Convective Warming System, Product Code: CWS5000 (110V).Care Essentials Pty., Ltd.DWJ
Z-0986-2020Class IICocoon Convective Warming System, Product Code: CWS4000 (110V).Care Essentials Pty., Ltd.DWJ
Z-1436-2020Class IIAtellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version...Siemens Healthcare Diagnostics Inc.N/A
Z-1435-2020Class IIAtellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version...Siemens Healthcare Diagnostics Inc.N/A
Z-1151-2020Class IIROSA One 3.1 Brain ApplicationMedTech SASHAW
Z-1150-2020Class IIROSA Brain 3.0 Application-BrainMedTech SASHAW
Z-0806-2020Class IIKodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic...Eastman Kodak CompanyKPR
Z-0996-2020Class IIGORE EXCLUDER Iliac Branch Endoprosthesis (IBE)W. L. Gore & Associates, Inc.MIH
Z-0995-2020Class IIGORE EXCLUDER AAA EndoprosthesisW. L. Gore & Associates, Inc.MIH