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 79 of 1190
FDA device recalls, page 79 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2057-2025Class IIPhilips L9-3 Transducer.Philips North America LLCITX
Z-2056-2025Class IIPhilips L8-4 Transducer.Philips North America LLCITX
Z-2055-2025Class IIPhilips L12-4 Transducer.Philips North America LLCITX
Z-2054-2025Class IIPhilips L12-3 Transducer.Philips North America LLCITX
Z-2053-2025Class IIPhilips eL18-4 EMT Transducer.Philips North America LLCITX
Z-2052-2025Class IIPhilips eL18-4 Transducer.Philips North America LLCITX
Z-2051-2025Class IIPhilips C9-5EC Transducer.Philips North America LLCITX
Z-2050-2025Class IIPhilips C5-2 Transducer.Philips North America LLCITX
Z-2049-2025Class IIPhilips C5-1 Transducer.Philips North America LLCITX
Z-2048-2025Class IIPhilips 3D9-3v Transducer.Philips North America LLCITX
Z-1969-2025Class IIAzurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4)...Philips Medical Systems Nederland B.V.OWB
Z-1914-2025Class IILong Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number...Stryker Corp.HSB
Z-2011-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW...Encore Medical, LPPHX
Z-2010-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW...Encore Medical, LPPHX
Z-2009-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW...Encore Medical, LPPHX
Z-2008-2025Class IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW...Encore Medical, LPPHX
Z-2018-2025Class IICDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK...Terumo Cardiovascular Systems CorporationDRY
Z-2101-2025Class IIO-arm O2 Imaging System. Mobile X-Ray System.Medtronic Navigation, IncOWB
Z-1957-2025Class IIKWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella...Microbiologics, Inc.JTR
Z-1361-2026Class IIBarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-HSTERIS CorporationKQM
Z-2133-2025Class IISigna Pet/mrGE HealthcareLNH
Z-2132-2025Class IIDiscovery MR750w 3.0TGE HealthcareLNH
Z-2131-2025Class IISIGNA Architect AIRGE HealthcareLNH
Z-2130-2025Class IISIGNA ArchitectGE HealthcareLNH
Z-2045-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2044-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2043-2025Class IIMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2069-2025Class IIApex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130...Corin LimitedJWH
Z-1927-2025Class IIEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled...Quantum Surgical SASJAK
Z-2033-2025Class IIJewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.Jewel Precision Sheet Metal & Machining, Inc.KCT
Z-1961-2025Class IMicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line...Integra LifeSciences CorporationFMF
Z-2016-2025Class IIOmnipod 5 Automated Insulin Delivery System, iOS Application. Model Number...Insulet CorporationQRX
Z-2197-2025Class IIIontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch...LTS Therapy Systems, LLCEGJ
Z-2196-2025Class IIIontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is...LTS Therapy Systems, LLCEGJ
Z-2072-2025Class IIChange Healthcare Cardiology Hemodynamics SoftwareChange Healthcare Canada CompanyMWI
Z-2071-2025Class IIChange Healthcare Cardiology Hemo SoftwareChange Healthcare Canada CompanyMWI
Z-2026-2025Class IIJewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number...Jewel Precision Sheet Metal & Machining, Inc.KCT
Z-2027-2025Class IIProduct: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;Siemens Healthcare Diagnostics Inc.JJE
Z-1960-2025Class IExtended Tip Applicator 8CM, Box of 1.Integra LifeSciences CorporationFMF
Z-1959-2025Class IExtended Tip Applicator, 15 CM, Box of 5.Integra LifeSciences CorporationFMF
Z-1958-2025Class IExtended Tip Applicator, 8CM, Box of 5.Integra LifeSciences CorporationFMF
Z-1940-2025Class IIFemoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.Stryker Corp.HSB
Z-1939-2025Class IIFemoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.Stryker Corp.HSB
Z-1993-2025Class IISTA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution...Diagnostica Stago, Inc.PPM
Z-1997-2025Class IIBigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP...Bigfoot Biomedical, Inc.QLG
Z-2007-2025Class IIREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2006-2025Class IIREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2005-2025Class IIREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2004-2025Class IIREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-2003-2025Class IIREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3...Becton Dickinson Infusion Therapy Systems Inc.FOZ