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 804 of 1190
FDA device recalls, page 804 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1566-201290-5970-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1565-201290-5970-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1564-201290-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height...Zimmer GmbHJWH
Z-1563-201290-5970-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1562-201200-5970-020-20 NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular...Zimmer GmbHJWH
Z-1561-201200-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint...Zimmer GmbHJWH
Z-1560-201200-5970-020-14, NexGen CR Complete Knee Solution, Articular Surface regular constraint...Zimmer GmbHJWH
Z-1559-201200-5970-020-12, NexGen CR Complete Knee Solution, Articular Surface regular constraint...Zimmer GmbHJWH
Z-1558-201200-5970-020-10, NexGen CR Complete Knee Solution, Articular Surface regular constraint...Zimmer GmbHJWH
Z-1557-201200-5970-020-09, NexGen CR Complete Knee Solution, Articular Surface regular constraint...Zimmer GmbHJWH
Z-1556-201290-5952-020-20, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene...Zimmer GmbHJWH
Z-1555-201290595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene...Zimmer GmbHJWH
Z-1554-201200-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene...Zimmer GmbHJWH
Z-1553-201290595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro...Zimmer GmbHJWH
Z-1552-201200-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene...Zimmer GmbHJWH
Z-1551-201200595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro...Zimmer GmbHJWH
Z-1550-201200595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro...Zimmer GmbHJWH
Z-1549-201200595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro...Zimmer GmbHJWH
Z-1548-201200595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro...Zimmer GmbHJWH
Z-1547-201200595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro...Zimmer GmbHJWH
Z-1445-2012Boston Scientific LATITUDE Patient Management System Communicator, Model 6476...Boston Scientific CorporationLWS
Z-1197-2012Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost...Philips Medical Systems Nederland B.V.IZI
Z-1196-2012Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips...Philips Medical Systems Nederland B.V.IZI
Z-1187-2021Class IIThyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO...Tosoh Bioscience IncJZO
Z-1503-2012Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the...MichClone Associates, Inc.GHM
Z-1502-2012BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100...MichClone Associates, Inc.GHM
Z-1501-2012Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test...MichClone Associates, Inc.GHM
Z-1314-2012Glendale Memorial Fx Pack Product Usage: The Sarns-Aortic Cannula is indicated for use...Terumo Cardiovascular Systems CorporationDWF
Z-1313-2012Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for...Terumo Cardiovascular Systems CorporationDWF
Z-1312-2012Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for...Terumo Cardiovascular Systems CorporationDWF
Z-1311-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer...Terumo Cardiovascular Systems CorporationDWF
Z-1310-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with...Terumo Cardiovascular Systems CorporationDWF
Z-1309-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with...Terumo Cardiovascular Systems CorporationDWF
Z-1308-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm...Terumo Cardiovascular Systems CorporationDWF
Z-1307-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr)...Terumo Cardiovascular Systems CorporationDWF
Z-1306-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8"...Terumo Cardiovascular Systems CorporationDWF
Z-1305-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer...Terumo Cardiovascular Systems CorporationDWF
Z-1304-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21...Terumo Cardiovascular Systems CorporationDWF
Z-1303-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr)...Terumo Cardiovascular Systems CorporationDWF
Z-1302-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8"...Terumo Cardiovascular Systems CorporationDWF
Z-1301-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer...Terumo Cardiovascular Systems CorporationDWF
Z-1300-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 8.0mm...Terumo Cardiovascular Systems CorporationDWF
Z-1299-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8"...Terumo Cardiovascular Systems CorporationDWF
Z-1298-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm...Terumo Cardiovascular Systems CorporationDWF
Z-1297-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm...Terumo Cardiovascular Systems CorporationDWF
Z-1296-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm...Terumo Cardiovascular Systems CorporationDWF
Z-1295-2012Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm...Terumo Cardiovascular Systems CorporationDWF
Z-1294-2012Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with...Terumo Cardiovascular Systems CorporationDWF
Z-1293-2012Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with...Terumo Cardiovascular Systems CorporationDWF
Z-1292-2012Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr)...Terumo Cardiovascular Systems CorporationDWF