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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 159 of 1190
FDA device recalls, page 159 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1263-2024Class IINo 3 Triathlon Ts Plus Tib Ins X3 Poly 11 MmHowmedica Osteonics CorpMBH
Z-1262-2024Class IIX3 Triathlon Cs Insert No 7 9 MmHowmedica Osteonics CorpMBH
Z-1261-2024Class IIX3 Triathlon Cs Insert No 6 11 MmHowmedica Osteonics CorpMBH
Z-1260-2024Class IIX3 Triathlon Cs Insert No 6 10 MmHowmedica Osteonics CorpMBH
Z-1259-2024Class IIX3 Triathlon Cs Insert No 3 10 MmHowmedica Osteonics CorpMBH
Z-1178-2024Class IIAzurion 7 with a Certeray generator-To perform image guidance in diagnostic...Philips Medical Systems Nederland B.V.OWB
Z-1177-2024Class IIAzurion 5 with a Certeray generator-To perform image guidance in diagnostic...Philips Medical Systems Nederland B.V.OWB
Z-1176-2024Class IIAzurion 3 with a Certeray generator -To perform image guidance in diagnostic...Philips Medical Systems Nederland B.V.OWB
Z-1695-2024Class IIAbbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOAbbott MedicalPNJ
Z-1293-2024Class IIEasyPoint Needle, 25G x 5/8", REF: 82091Retractable Technologies, Inc.FMI
Z-1284-2024Class ICERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c)...Medos International SARLQJP
Z-1294-2024Class IIBVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation...Becton Dickinson & CoHMX
Z-1190-2024Class IIIWash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number...Abbott Molecular, Inc.OOI
Z-1189-2024Class IIIIn-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF...Abbott Molecular, Inc.MVU
Z-1223-2024Class IIBD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower...CareFusion 303, IncBRY
Z-1188-2024Class IIIIn-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF...Abbott Molecular, Inc.OYU
Z-1594-2024Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog...Randox Laboratories, LimitedDDZ
Z-1593-2024Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin...Randox Laboratories, LimitedJIT
Z-1460-2024Class IITrumpet, Needle Guide, Cat# TMS-200Technicality Inc.MDM
Z-1389-2024Class IIEpix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit...Applied Medical Resources CorpMDM
Z-1388-2024Class IIEpix Universal Clip Applier, REF: CA500, STERILEEOApplied Medical Resources CorpMDM
Z-1348-2024Class IIMINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous...Boston Scientific CorporationDRE
Z-1347-2024Class IIMINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1346-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous...Boston Scientific CorporationDRE
Z-1345-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous...Boston Scientific CorporationDRE
Z-1344-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1343-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous...Boston Scientific CorporationDRE
Z-1342-2024Class IIMINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous...Boston Scientific CorporationDRE
Z-1341-2024Class IIMINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1340-2024Class IIMINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1339-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog...Boston Scientific CorporationDRE
Z-1338-2024Class IIMINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous...Boston Scientific CorporationDRE
Z-1337-2024Class IIMINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1336-2024Class IIMINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1335-2024Class IIMINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1334-2024Class IIMINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous...Boston Scientific CorporationDRE
Z-1385-2024Class IISOLTIVE Premium SuperPulsed Laser (TFL-PLS )OLYMPUS Corporation of the AmericasGEX
Z-1384-2024Class IISOLTIVE Pro SuperPulsed Laser (TFL-SLS )OLYMPUS Corporation of the AmericasGEX
Z-1258-2024Class IIEmbrace Drill Tower, Standard/Lateral (25mm)Waldemar Link GmbH & Co. KGHTW
Z-1257-2024Class IIEmbrace Drill Tower, Wedged (25mm)Waldemar Link GmbH & Co. KGHTW
Z-1292-2024Class IIShimadzu, Trinias, Digital Angiography SystemShimadzu Corporation Medical Systems DivisionOWB
Z-1191-2024Class IINxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for...NxStage Medical IncKDI
Z-1250-2024Class IIVantage Titan, Model: MRT-1504Canon Medical Systems USA, Inc.LNH
Z-1249-2024Class IIMRI system: Vantage Elan, Model: MRT-2020Canon Medical Systems USA, Inc.LNH
Z-1248-2024Class IIMRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550Canon Medical Systems USA, Inc.LNH
Z-1320-2024Class III.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180In2Bones SASHWC
Z-1319-2024Class III.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175In2Bones SASHWC
Z-1233-2024Class IIVITROS XT 7600 Integrated System, Catalog No. 6844461Ortho-Clinical Diagnostics, Inc.JJE
Z-1232-2024Class IIVITROS XT 3400 Chemistry System, Catalog No. 6844458Ortho-Clinical Diagnostics, Inc.JJE
Z-1231-2024Class IIVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)Ortho-Clinical Diagnostics, Inc.JJE