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 396 of 1190
FDA device recalls, page 396 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1689-2019Class IIOpteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45Exactech, Inc.MQV
Z-1688-2019Class IIOpteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30Exactech, Inc.MQV
Z-1376-2019Class IPortico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20Terumo Medical Corp.DYB
Z-1375-2019Class ISOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025...Terumo Medical Corp.DYB
Z-1374-2019Class ISOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435...Terumo Medical Corp.DYB
Z-1619-2020Class IIC-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI...The Binding Site Group Ltd.DCN
Z-2203-2019Class IIEndoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes...MEDLINE INDUSTRIES, LP - NorthfieldMNL
Z-2100-2019Class IILidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product...Astra, LLCRFC
Z-1824-2019Class II2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee...Mako Surgical Corp.OLO
Z-1823-2019Class II2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)Mako Surgical Corp.OLO
Z-2125-2020Class IIFifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage...Boston Scientific Neuromodulation CorporationNHL
Z-2124-2020Class IIFifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage...Boston Scientific Neuromodulation CorporationLGW
Z-2123-2020Class IIPrecision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is...Boston Scientific Neuromodulation CorporationLGW
Z-2122-2020Class IIThe LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal...Boston Scientific Neuromodulation CorporationLGW
Z-2121-2020Class IILinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a...Boston Scientific Neuromodulation CorporationLGW
Z-2120-2020Class IIThirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package...Boston Scientific Neuromodulation CorporationLGW
Z-2119-2020Class IIArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical...Boston Scientific Neuromodulation CorporationLGW
Z-0107-2020Class IIUvc Tray Uvt875Centurion Medical Products, LPLRP
Z-0106-2020Class IITriple Lumen Cvc 20Cm Bundle Stcvc2040Centurion Medical Products, LPOES
Z-0105-2020Class IIInvasive Procedure Tray Mns9510Centurion Medical Products, LPLRP
Z-0104-2020Class IIIV Kit - Sorbaview Ivs3475Centurion Medical Products, LPLRS
Z-0103-2020Class IIIV Securement Kit Ivs3405Centurion Medical Products, LPLRS
Z-0102-2020Class IIIV Start Kit Iv8440Centurion Medical Products, LPLRS
Z-0101-2020Class IIVantex 7Fr, 16Cm, 3L Cvc Bundle Ecvc6670Centurion Medical Products, LPOES
Z-0100-2020Class IIOr Vantex 7Fr 3L 16Cm Cvc Ecvc6665Centurion Medical Products, LPOES
Z-0099-2020Class IICentral Line Bundle 16Cm Multimed Ecvc6545aCenturion Medical Products, LPOES
Z-0098-2020Class IICentral Line Bundle 16Cm Multimed Ecvc6545Centurion Medical Products, LPOES
Z-0097-2020Class IICentral Line Bundle Ecvc6375Centurion Medical Products, LPOES
Z-0096-2020Class IICvc Insertion Bundle 8.5Fr 4L 16Cm Ecvc6355Centurion Medical Products, LPOES
Z-0095-2020Class IICvc Triple Lumen Safety Bundle Ecvc6070Centurion Medical Products, LPOES
Z-0094-2020Class IICvc Bundle Vantex 7F, 3L, 20Cm Ecvc6065Centurion Medical Products, LPOES
Z-0093-2020Class IICvc Bundle Multimed, 3L, 20Cm Ecvc6060Centurion Medical Products, LPOES
Z-0092-2020Class IICvc Bundle, 20Cm, 3L, Pi Ecvc5120aCenturion Medical Products, LPOES
Z-0091-2020Class IICvc Bundle, 20Cm, 3L, Pi Ecvc5120Centurion Medical Products, LPOES
Z-0090-2020Class IICvc Bundle, 20Cm, 4L, Pi Ecvc5095Centurion Medical Products, LPOES
Z-0089-2020Class IICentral Venous Access Device Bundle Ecvc2840Centurion Medical Products, LPOES
Z-0088-2020Class IITriple Lumen Bundle Kit Ecvc1540Centurion Medical Products, LPOES
Z-0087-2020Class IICap Bundle Kit Dyndc2137Centurion Medical Products, LPLRP
Z-0086-2020Class IISterile Cap Change Kit Dyndc1946bCenturion Medical Products, LPOXQ
Z-0085-2020Class IIInfusa Port Kit Dyndc1840fCenturion Medical Products, LPLRS
Z-0084-2020Class IIInfusa Port Kit Dyndc1840eCenturion Medical Products, LPLRP
Z-0083-2020Class IICap Change Kit Dyndc1496bCenturion Medical Products, LPOXQ
Z-0082-2020Class IINeonatal Cap Change Kit DT20315Centurion Medical Products, LPOXQ
Z-0081-2020Class IICap Change Kit DT20310Centurion Medical Products, LPOXQ
Z-0080-2020Class IIPort and Io Access Dressing Kit Dt15780aCenturion Medical Products, LPOXQ
Z-0079-2020Class IICvc Bundle without Cath Cvi4600Centurion Medical Products, LPLRP
Z-0078-2020Class IINeonatal Procedure Tray Picc Catheters Cvi4535Centurion Medical Products, LPLRP
Z-0077-2020Class IIPediatric Picc Insertion Tray Cvi4450aCenturion Medical Products, LPLRS
Z-0076-2020Class IIPediatric Picc Insertion Tray Cvi4450Centurion Medical Products, LPLRS
Z-0075-2020Class IIPICC Line Accessory Kit CVI4285Centurion Medical Products, LPLRS