510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 168 of 1190
FDA device recalls, page 168 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1051-2024Class IDover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML...Medtronic, Inc.GBM
Z-1050-2024Class IDover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG...Medtronic, Inc.EZL
Z-1049-2024Class IDover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR...Medtronic, Inc.KYZ
Z-1048-2024Class IDover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN...Medtronic, Inc.FCN
Z-1047-2024Class IDover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML...Medtronic, Inc.FFG
Z-1046-2024Class IDover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY...Medtronic, Inc.KNX
Z-1045-2024Class IDover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML...Medtronic, Inc.FCM
Z-1044-2024Class ITrach Kit W/hydrogen & SaliMedtronic, Inc.BTO
Z-1043-2024Class IArgyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle"...Medtronic, Inc.JOL
Z-0926-2024Class IITIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0925-2024Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0924-2024Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0923-2024Class IIPS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0922-2024Class IIDUR PCA MTK REV INS RT Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0921-2024Class IIDUR PCA MTK REV INS RT Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0920-2024Class IIDUR PCA MTK REV INS LFT Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0919-2024Class IIDUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609Howmedica Osteonics CorpJWH
Z-0918-2024Class IIDURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number...Howmedica Osteonics CorpJWH
Z-0917-2024Class IIDURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0916-2024Class IIDURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0915-2024Class IILARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0914-2024Class IIPRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number...Howmedica Osteonics CorpJWH
Z-0913-2024Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product...Howmedica Osteonics CorpJWH
Z-0912-2024Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0911-2024Class IIRGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product...Howmedica Osteonics CorpJWH
Z-0910-2024Class IILEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number...Howmedica Osteonics CorpJWH
Z-0909-2024Class IILEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number...Howmedica Osteonics CorpJWH
Z-0908-2024Class IILEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0907-2024Class IILEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0906-2024Class IILEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0905-2024Class IIP7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number...Howmedica Osteonics CorpLWJ
Z-0904-2024Class IIP7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107Howmedica Osteonics CorpLWJ
Z-0903-2024Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0902-2024Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0901-2024Class IIHOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0900-2024Class IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0899-2024Class IIScorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0898-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910Howmedica Osteonics CorpJWH
Z-0897-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710Howmedica Osteonics CorpJWH
Z-0896-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708Howmedica Osteonics CorpJWH
Z-0895-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508Howmedica Osteonics CorpJWH
Z-0894-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308Howmedica Osteonics CorpJWH
Z-0893-2024Class IISCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110Howmedica Osteonics CorpJWH
Z-0892-2024Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee...Howmedica Osteonics CorpJWH
Z-0891-2024Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0890-2024Class IISCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee...Howmedica Osteonics CorpJWH
Z-0889-2024Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee...Howmedica Osteonics CorpJWH
Z-0888-2024Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee...Howmedica Osteonics CorpJWH
Z-0887-2024Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee...Howmedica Osteonics CorpJWH
Z-0886-2024Class IISCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee...Howmedica Osteonics CorpJWH