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 49 of 1190
FDA device recalls, page 49 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0590-2026Class IErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of...Draeger, Inc.BZA
Z-1232-2026Class IIBrand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical...Intuitive Surgical, Inc.NAY
Z-0955-2026Class IIBrand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure...Rocket MedicalGBX
Z-0954-2026Class IIBrand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure...Rocket MedicalGBX
Z-0953-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety...Rocket MedicalGBX
Z-0952-2026Class IIBrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure...Rocket MedicalGBX
Z-0951-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety...Rocket MedicalGBX
Z-0950-2026Class IIBrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure...Rocket MedicalGBX
Z-0889-2026Class IIAccess 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient...Siemens Healthcare Diagnostics Inc.JJE
Z-0908-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826C.R. Bard IncFAD
Z-0907-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630C.R. Bard IncFAD
Z-0906-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426C.R. Bard IncFAD
Z-0905-2026Class IIBard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614C.R. Bard IncFAD
Z-0940-2026Class IIMADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)PathGWJ
Z-1217-2026Class IIBD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System...CareFusion 303, IncFRN
Z-0887-2026Class IISafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,Bard Peripheral Vascular IncPXI
Z-0992-2026Class IIBrand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0991-2026Class IIBrand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0990-2026Class IIBrand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0989-2026Class IIBrand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0988-2026Class IIBrand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0987-2026Class IIBrand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate...Diasol, IncKPO
Z-0880-2026Class IIHemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with...Accriva Diagnostics, Inc.JBP
Z-0724-2026Class IIXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.CepheidPEU
Z-0917-2026Class IICardiosave Rescue. Intra-Aortic Balloon Pump system.Datascope Corp.DSP
Z-0916-2026Class IICardiosave Hybrid. Intra-Aortic Balloon Pump system.Datascope Corp.DSP
Z-1157-2026Class IISQ40S Blood Transfusion FilterGVS TM, IncCAK
Z-0935-2026Class IIGE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing systemGE HealthcareLLZ
Z-0586-2026Class IIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing...Fresenius Kabi USA, LLCFRN
Z-0848-2026Class IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Fresenius Kabi USA, LLCFRN
Z-0818-2026Class II8 in 1 STI Test KitGet Tested International ABOUY
Z-0817-2026Class II3 in 1 STI TestGet Tested International ABOUY
Z-0816-2026Class II2 in 1 Trichomonas / Gardnerella TestGet Tested International ABOUY
Z-0815-2026Class IISerotonin TestGet Tested International ABCDA
Z-0814-2026Class IIPollen Allergy TestGet Tested International ABDHB
Z-0813-2026Class IIPet Allergy TestGet Tested International ABDHB
Z-0812-2026Class IIMelatonin TestGet Tested International ABLMG
Z-0811-2026Class IIIron Deficiency Test (ferritin)Get Tested International ABLMG
Z-0810-2026Class IIIodine TestGet Tested International ABJIJ
Z-0809-2026Class IIHeavy Metals TestGet Tested International ABJMG
Z-0808-2026Class IIFood Intolerance Test SmallGet Tested International ABDHB
Z-0807-2026Class IIFood Intolerance Test MediumGet Tested International ABDHB
Z-0806-2026Class IIFood Intolerance Test LargeGet Tested International ABDHB
Z-0805-2026Class IIEstrogen & Progesterone TestGet Tested International ABCHM
Z-0804-2026Class IIAllergy test SmallGet Tested International ABNHG
Z-0803-2026Class IIAllergy test SmallGet Tested International ABDHB
Z-0802-2026Class IIAllergy & Food Intolerance TestGet Tested International ABQWZ
Z-0801-2026Class IILiver TestGet Tested International ABQWZ
Z-0800-2026Class IIKidney TestGet Tested International ABQWZ
Z-0799-2026Class IIDiabetes Test (ketones & glucose)Get Tested International ABJIL