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 122 of 1190
FDA device recalls, page 122 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3288-2024Class IIAGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3287-2024Class IIAGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3286-2024Class IIWALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3285-2024Class IIWALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3284-2024Class IIWALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3247-2024Class IIBD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial...Becton Dickinson & CoLON
Z-3246-2024Class IIBD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial...Becton Dickinson & CoLON
Z-3283-2024Class IIWALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3282-2024Class IIWALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3281-2024Class IIWALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3280-2024Class IIWALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3279-2024Class IIWALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3278-2024Class IIWALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3277-2024Class IIWALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully...Boston Scientific CorporationESW
Z-3276-2024Class IIWALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3275-2024Class IIWALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3274-2024Class IIWALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3273-2024Class IIWALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3272-2024Class IIWALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency...Boston Scientific CorporationESW
Z-3271-2024Class IIWALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3270-2024Class IIWALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3269-2024Class IIWALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3268-2024Class IIWALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3267-2024Class IIWALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3266-2024Class IIWALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-3265-2024Class IIWALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully...Boston Scientific CorporationESW
Z-2721-2024Class ILVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty...Fresenius Kabi USA, LLCFPA
Z-0118-2025Class IIIMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when...Siemens Healthcare Diagnostics Inc.DEW
Z-3189-2024Class IIStainless Steel Sims Uterine Sound, Part Number 64-601CooperSurgical, Inc.HHM
Z-3188-2024Class IISilver-Plated Copper Sims Uterine Sound, Part Number 64-600CooperSurgical, Inc.HHM
Z-0041-2025Class IIInspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation...Inspire Medical Systems IncMNQ
Z-0040-2025Class IIInspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway...Inspire Medical Systems IncMNQ
Z-0003-2025Class IMiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780...Medtronic, Inc.OZP
Z-0002-2025Class IMiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump...Medtronic, Inc.OYC
Z-0001-2025Class IMiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed...Medtronic, Inc.OZO
Z-3065-2024Class IIDimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number...Siemens Healthcare Diagnostics Inc.CIG
Z-2738-2024Class IIDR 800. Digital Radiography X-ray System.Agfa N.V.JAA
Z-3064-2024Class IIADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number...Siemens Healthcare Diagnostics Inc.CEK
Z-3063-2024Class IIAtellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN)...Siemens Healthcare Diagnostics Inc.CEK
Z-3299-2024Class IIArrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025"...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-3161-2024Class IIIBiomarC EX Fiducial Marker System, Catalog Number 040165Carbon Medical Technologies, Inc.IYE
Z-3104-2024Class IIADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement...Siemens Healthcare Diagnostics Inc.NIG
Z-3103-2024Class IIADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement...Siemens Healthcare Diagnostics Inc.NIG
Z-3102-2024Class IIAtellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative...Siemens Healthcare Diagnostics Inc.NIG
Z-3101-2024Class IIAtellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement...Siemens Healthcare Diagnostics Inc.NIG
Z-3100-2024Class IIAtellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of...Siemens Healthcare Diagnostics Inc.NIG
Z-2939-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2938-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2937-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD
Z-2936-2024Class IIBVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes...Becton Dickinson & CoKDD