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

59,336 records, page 21 of 1187
FDA device recalls, page 21 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2306-2026Class IIMAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System...GE Medical Systems China Co., Ltd.DXH
Z-2377-2026Class IDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X...Arrow International LLC (subsidiary of Teleflex Incorporated)DQY
Z-2376-2026Class IDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X...Arrow International LLC (subsidiary of Teleflex Incorporated)LRS
Z-2375-2026Class IDescription/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR...Arrow International LLC (subsidiary of Teleflex Incorporated)LRS
Z-2374-2026Class IDescription/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20...Arrow International LLC (subsidiary of Teleflex Incorporated)NIE
Z-2373-2026Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT...Arrow International LLC (subsidiary of Teleflex Incorporated)MPB
Z-2372-2026Class IDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1AArrow International LLC (subsidiary of Teleflex Incorporated)PPO
Z-2371-2026Class IDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL...Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-2370-2026Class IDescription/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA...Arrow International LLC (subsidiary of Teleflex Incorporated)PWR
Z-2369-2026Class IDescription/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4...Arrow International LLC (subsidiary of Teleflex Incorporated)OFC
Z-2368-2026Class IDescription/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1...Arrow International LLC (subsidiary of Teleflex Incorporated)OFB
Z-2367-2026Class IDescription/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4...Arrow International LLC (subsidiary of Teleflex Incorporated)OEZ
Z-2366-2026Class IDescription/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR...Arrow International LLC (subsidiary of Teleflex Incorporated)OES
Z-2365-2026Class IDescription/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC...Arrow International LLC (subsidiary of Teleflex Incorporated)POZ
Z-2364-2026Class IDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH...Arrow International LLC (subsidiary of Teleflex Incorporated)CAZ
Z-2638-2026Class IIAdapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction...Baxter Healthcare CorporationGDC
Z-2363-2026Class IParacentesis Kit, Ref: Ak-00376, Ask-00376-VcuArrow International LLC (subsidiary of Teleflex Incorporated)PYC
Z-2222-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965...Medtronic Perfusion SystemsDWF
Z-2221-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915...Medtronic Perfusion SystemsDWF
Z-2220-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L...Medtronic Perfusion SystemsDWF
Z-2219-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913...Medtronic Perfusion SystemsDWF
Z-2218-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725...Medtronic Perfusion SystemsDWF
Z-2217-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665...Medtronic Perfusion SystemsDWF
Z-2216-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T...Medtronic Perfusion SystemsDWF
Z-2215-2026Class IIMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T...Medtronic Perfusion SystemsDWF
Z-2214-2026Class IIMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T...Medtronic Perfusion SystemsDWF
Z-2509-2026Class IIProduct Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product...Staar Surgical AGMTA
Z-2913-2026Class IInavify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital...Ventana Medical Systems IncPSY
Z-2294-2026Class IIDigital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System...Shimadzu Medical SystemsOWB
Z-2318-2026Class IIAllia Moveo angiographic X-ray systemGE HealthcareOWB
Z-2317-2026Class IIAllia IGS Pulse angiographic X-ray systemGE HealthcareOWB
Z-2316-2026Class IIAllia IGS 7 Pulse angiographic X-ray systemGE HealthcareOWB
Z-2315-2026Class IIAllia IGS 5 Pulse angiographic X-ray systemGE HealthcareOWB
Z-2314-2026Class IIAllia IGS 3 Pulse angiographic X-ray systemGE HealthcareOWB
Z-2211-2026Class IAutomated Impella Controller (AIC); Product Code: 0042-0000-US;Abiomed, Inc.OZD
Z-2362-2026Class IIBrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number...The Binding Site Group Ltd.OTA
Z-2280-2026Class IIFresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100Fresh Roast Systems IncRDW
Z-2281-2026Class IICovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;Medtronic, Inc.OCW
Z-2261-2026Class IICOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code...Medtronic, Inc.JOH
Z-1969-2026Class IIPhilips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.Philips North America LLCLNH
Z-1968-2026Class IIPhilips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number...Philips North America LLCLNH
Z-1967-2026Class IIPhilips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model...Philips North America LLCLNH
Z-1966-2026Class IIPhilips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number...Philips North America LLCLNH
Z-1965-2026Class IIPhilips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number...Philips North America LLCLNH
Z-1964-2026Class IIPhilips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model...Philips North America LLCLNH
Z-1963-2026Class IIPhilips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358...Philips North America LLCLNH
Z-1962-2026Class IIPhilips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357...Philips North America LLCLNH
Z-1961-2026Class IIPhilips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356...Philips North America LLCLNH
Z-1960-2026Class IIPhilips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359...Philips North America LLCLNH
Z-1959-2026Class IIPhilips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2...Philips North America LLCLNH