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 81 of 1190
FDA device recalls, page 81 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1966-2025Class IIAllon 2001. Part Number: 200-00263Belmont Medical TechnologiesDWJ
Z-1919-2025Class IIKendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall...Medtronic, Inc.JOW
Z-1918-2025Class IIKendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall...Medtronic, Inc.JOW
Z-1917-2025Class IISCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used...Medtronic, Inc.JOW
Z-2722-2026Class IIda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Intuitive Surgical, Inc.NAY
Z-2070-2025Class IIThe HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201...HemoCue ABCGA
Z-1946-2025Class IDexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006...Dexcom, Inc.QBJ
Z-1945-2025Class IDexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013...Dexcom, Inc.QBJ
Z-1869-2025Class IIVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing...Fresenius Kabi USA, LLCFPA
Z-1974-2025Class IIBD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF...BD Switzerland SARLFPA
Z-1973-2025Class IIBd Texium Closed Male Luer with Female Cap, Ref: 10012241-0500BD Switzerland SARLFPA
Z-1964-2025Class IIBaxter Novum IQ Syringe Pump, product code 40800BAXUS,Baxter Healthcare CorporationFRN
Z-1944-2025Class IDexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012...Dexcom, Inc.QBJ
Z-1972-2025Class IIBD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20...BD Switzerland SARLFMF
Z-1943-2025Class IDexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001...Dexcom, Inc.QBJ
Z-1971-2025Class IIBD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010...BD Switzerland SARLFMF
Z-1970-2025Class IIAlaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap...BD Switzerland SARLFPA
Z-2037-2025Class IBiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of...Respironics, Inc.MNT
Z-2036-2025Class IBiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and...Respironics, Inc.MNS
Z-2035-2025Class IBiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for...Respironics, Inc.MNS
Z-2040-2025Class IIBrand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1)...Ortho-Clinical Diagnostics, Inc.JJE
Z-2039-2025Class IIBrand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number...Ortho-Clinical Diagnostics, Inc.JJE
Z-2038-2025Class IIBrand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1)...Ortho-Clinical Diagnostics, Inc.JJE
Z-1994-2025Class IIModel: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331...Barco N.V.DXJ
Z-1962-2025Class II2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles...Baxter Healthcare CorporationERA
Z-1989-2025Class IIPrestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810...Balt USA, LLCKRD
Z-1980-2025Class IIGCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SOhio Medical LLCCAW
Z-1988-2025Class IIOptima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 0081006856888...Balt USA, LLCHCG
Z-2017-2025Class IIProduct Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis...CareFusion 303, IncBRY
Z-2477-2025Class IIBD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main /...CareFusion 303, IncBRY
Z-2046-2025Class IIIBrand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age...Lumithera, Inc.SDE
Z-1996-2025Class IIDxI 9000 Access Immunoassay Analyzer C11137Siemens Healthcare Diagnostics Inc.JJE
Z-1975-2025Class IIBrand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade...MicroAire Surgical Instruments, LLCEMF
Z-1868-2025Class IZ-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids...Zyno Medical LLC.FRN
Z-1867-2025Class IZ-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids...Zyno Medical LLC.FRN
Z-1866-2025Class IZ-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids...Zyno Medical LLC.FRN
Z-1865-2025Class IZ-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids...Zyno Medical LLC.FRN
Z-1925-2025Class IIBrand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB...Natus Medical IncorporatedOMA
Z-0033-2026Class IIMedtronic, Simplera Sensor, REF: MMT-5100JD1Medtronic, Inc.MDS
Z-2041-2025Class IIHardyCHROM CRE, selective and differential culture medium for antimicrobial...Hardy DiagnosticsJSO
Z-1816-2025Class IIAffinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433...Baxter Healthcare CorporationKNC
Z-1812-2025Class IIPhenoMATRIXCopan WASPKZB
Z-1923-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser...OLYMPUS Corporation of the AmericasGEX
Z-1922-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser...OLYMPUS Corporation of the AmericasGEX
Z-1921-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed...OLYMPUS Corporation of the AmericasGEX
Z-1920-2025Class IIBrand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser...OLYMPUS Corporation of the AmericasGEX
Z-0372-2026Class IISAFE-T-FILL Micro Capillary Blood Collection, 125 L Prepared with Dipotassium EDTA...ASP Global, LLCJKA
Z-1901-2025Class IIAccess Testosterone assay, Catalog Number 33560Siemens Healthcare Diagnostics Inc.CDZ
Z-1911-2025Class IIOlympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190VOLYMPUS Corporation of the AmericasNWB
Z-1906-2025Class IIDexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous...Dexcom, Inc.QBJ