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 357 of 1190
FDA device recalls, page 357 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1038-2020Class IIAAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545Medtronic, Inc.FYA
Z-1037-2020Class IIAAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515Medtronic, Inc.FYA
Z-1036-2020Class IIAAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541ELMedtronic, Inc.FYA
Z-1035-2020Class IIAAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541Medtronic, Inc.FYA
Z-1034-2020Class IIAAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511Medtronic, Inc.FYA
Z-1033-2020Class IIAAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545Medtronic, Inc.FYA
Z-1032-2020Class IIGOWN SURG LG W/TOWEL ST BACK, Item Code 9515Medtronic, Inc.FYA
Z-1031-2020Class IIAAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995Medtronic, Inc.FYA
Z-1030-2020Class IIAAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599Medtronic, Inc.FYA
Z-1029-2020Class IIAAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575ELMedtronic, Inc.FYA
Z-1028-2020Class IIAAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575Medtronic, Inc.FYA
Z-1027-2020Class IIROYALSILK XLARGE, Gown. Item Code 9548Medtronic, Inc.FYA
Z-1026-2020Class IIAAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571Medtronic, Inc.FYA
Z-1025-2020Class IIAAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541Medtronic, Inc.FYA
Z-1024-2020Class IIROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998Medtronic, Inc.FYA
Z-1023-2020Class IIROYALSILK 2XLARGE, Gown. Item Code 9578Medtronic, Inc.FYA
Z-1022-2020Class IIROYALSILK LARGE, Gown. Item Code 9518Medtronic, Inc.FYA
Z-1021-2020Class IIAAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585NMedtronic, Inc.FYA
Z-1020-2020Class IIAAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNAMedtronic, Inc.FYA
Z-1019-2020Class IIAAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NCMedtronic, Inc.FYA
Z-1018-2020Class IIAAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NBMedtronic, Inc.FYA
Z-1017-2020Class IIAAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NAMedtronic, Inc.FYA
Z-1016-2020Class IIAAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NBMedtronic, Inc.FYA
Z-1015-2020Class IIAAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995NMedtronic, Inc.FYA
Z-1014-2020Class IIROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998NMedtronic, Inc.FYA
Z-1013-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NBMedtronic, Inc.FYA
Z-1012-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NCMedtronic, Inc.FYA
Z-1011-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NCMedtronic, Inc.FYA
Z-1010-2020Class IIAAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NCMedtronic, Inc.FYA
Z-1009-2020Class IIAAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NCMedtronic, Inc.FYA
Z-1008-2020Class IIAAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NBMedtronic, Inc.FYA
Z-1007-2020Class IIAAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NBMedtronic, Inc.FYA
Z-1006-2020Class IIAAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NBMedtronic, Inc.FYA
Z-1005-2020Class IIAAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NAMedtronic, Inc.FYA
Z-1004-2020Class IIAAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NBMedtronic, Inc.FYA
Z-1003-2020Class IIAAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NBMedtronic, Inc.FYA
Z-1002-2020Class IIAAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NAMedtronic, Inc.FYA
Z-1420-2020Class IIAIA-360 Automated Immunoassay Analyzer, Product Code 019945Tosoh Bioscience IncKHO
Z-1388-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1387-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1386-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference...ZimVie US Corp LLCNHA
Z-1385-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference...ZimVie US Corp LLCNHA
Z-1384-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1383-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1382-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1381-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1380-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1379-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1378-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number...ZimVie US Corp LLCNHA
Z-1377-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number...ZimVie US Corp LLCNHA