510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 69 of 1190
FDA device recalls, page 69 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0533-2026Class IIPhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802...Merit Medical Systems, Inc.DTL
Z-0032-2026Class IIDxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i...Siemens Healthcare Diagnostics Inc.CGR
Z-2334-2025Class INovum IQ Syringe Pump, Product Code 40700BAX, infusion pumpBaxter Healthcare CorporationFRN
Z-2333-2025Class INovum IQ Syringe Pump, Product Code 40800BAXUS, infusion pumpBaxter Healthcare CorporationFRN
Z-2332-2025Class INovum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pumpBaxter Healthcare CorporationFRN
Z-2504-2025Class IIInterventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the...Philips Medical Systems Nederland B.V.OWB
Z-2503-2025Class IIPhilips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x)...Philips Medical Systems Nederland B.V.OWB
Z-2502-2025Class IIPhilips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x)...Philips Medical Systems Nederland B.V.OWB
Z-2614-2025Class IReprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal...MEDLINE INDUSTRIES, LP - NorthfieldOWQ
Z-2613-2025Class IReprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and...MEDLINE INDUSTRIES, LP - NorthfieldOWQ
Z-2612-2025Class IReprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-2611-2025Class IReprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-2610-2025Class IReprocessed Livewire Steerable Electrophysiology Catheter Item Numbers...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-2541-2025Class IILinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN...Waldemar Link GmbH & Co. KGJWH
Z-2519-2025Class IIBrand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218...Lumicell, Inc.SAW
Z-0017-2026Class IIImplant Epikut Plus Mt16 3,5X10,0mm, Ref: Ilm 3510N; Implant Epikut Plus Mt16 3.8X11.5mm...S.I.N. Implant System LtdaDZE
Z-2532-2025Class IIBrand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath...Contract Medical International GmbHDYB
Z-2337-2025Class IIClearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number...Mckesson Medical-Surgical Inc. Corporate OfficeGTY
Z-2560-2025Class IIVITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5...Ortho-Clinical Diagnostics, Inc.KHP
Z-2559-2025Class IIChemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5...Ortho-Clinical Diagnostics, Inc.KHP
Z-2436-2025Class IWATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to...Boston Scientific CorporationDQY
Z-2435-2025Class IWATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to...Boston Scientific CorporationDQY
Z-2434-2025Class IWATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to...Boston Scientific CorporationDQY
Z-2433-2025Class IWATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to...Boston Scientific CorporationDQY
Z-2432-2025Class IWATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to...Boston Scientific CorporationDQY
Z-2431-2025Class IWATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to...Boston Scientific CorporationDQY
Z-2430-2025Class IWATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to...Boston Scientific CorporationDQY
Z-2429-2025Class IWATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to...Boston Scientific CorporationDQY
Z-2428-2025Class IWATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to...Boston Scientific CorporationDQY
Z-2427-2025Class IWATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to...Boston Scientific CorporationDQY
Z-2426-2025Class IWATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to...Boston Scientific CorporationDQY
Z-2615-2025Class IIOrtoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number...Ortoma ABOLO
Z-2439-2025Class IITherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702...Baxter Healthcare CorporationKDI
Z-2438-2025Class IIPrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724Baxter Healthcare CorporationKDI
Z-2437-2025Class IIPrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627...Baxter Healthcare CorporationKDI
Z-2553-2025Class II10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 /...Merit Medical Systems, Inc.DTL
Z-2639-2025Class IIZAP-X Radiosurgery System, Model: 300150Zap Surgical Systems Inc.IYE
Z-2567-2025Class IMedline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2566-2025Class IMedline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-0226-2026Class IIIOne Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854...Home Health US, IncorporatedQRL
Z-2339-2025Class IIElectrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator...OLYMPUS Corporation of the AmericasGEI
Z-2338-2025Class IIElectrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator...OLYMPUS Corporation of the AmericasGEI
Z-1609-2026Class IIMicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are...Siemens Healthcare Diagnostics Inc.LTT
Z-2327-2025Class IRELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent...Boston Scientific CorporationNVY
Z-2326-2025Class IENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent...Boston Scientific CorporationNVY
Z-2325-2025Class IENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter...Boston Scientific CorporationLWS
Z-2422-2025Class IIBrand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number...Dentsply IH BVNDP
Z-2421-2025Class IIBrand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number...Dentsply IH BVNDP
Z-2419-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number...Thor Photomedicine Inc.ILY
Z-2418-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number...Thor Photomedicine Inc.ILY