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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 167 of 1190
FDA device recalls, page 167 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2291-2026Class IIPhilips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0...Philips Medical Systems Nederland B.V.OWB
Z-2290-2026Class IIPhilips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0...Philips Medical Systems Nederland B.V.OWB
Z-2289-2026Class IIPhilips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0...Philips Medical Systems Nederland B.V.OWB
Z-2288-2026Class IIPhilips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0...Philips Medical Systems Nederland B.V.OWB
Z-2287-2026Class IIPhilips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1...Philips Medical Systems Nederland B.V.OWB
Z-2286-2026Class IIPhilips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1...Philips Medical Systems Nederland B.V.OWB
Z-2285-2026Class IIPhilips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0...Philips Medical Systems Nederland B.V.OWB
Z-2284-2026Class IIPhilips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1...Philips Medical Systems Nederland B.V.OWB
Z-0722-2024Class IIMINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN)...Cook Medical LLCMQG
Z-0779-2024Class IICobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1Medtronic, Inc.LWS
Z-0719-2024Class IIIncisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable...Philips North America LLCJAK
Z-0642-2024Class IExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100Globus Medical, Inc.OLO
Z-0837-2024Class IITerragene Bionova PCD (PCD222-C)Terragene LLCFRC
Z-0836-2024Class IITerragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical...Terragene LLCJOJ
Z-0778-2024Class IIAccure Laser System, Model: PFMS00004Accure Acne, IncGEX
Z-1085-2024Class IIStryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cmStryker Corp.QJP
Z-1084-2024Class IIStryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cmStryker Corp.DQO
Z-0636-2024Class IIImpella Connect, software portal for online device management that allows clinicians and...Abiomed, Inc.PYX
Z-0669-2024Class IIVascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM...Baxter Healthcare CorporationDXZ
Z-0668-2024Class IIPERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM...Baxter Healthcare CorporationDXZ
Z-0667-2024Class IIBaxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883Baxter Healthcare CorporationPMX
Z-0666-2024Class IIVascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS...Baxter Healthcare CorporationPSQ
Z-0665-2024Class IIPeri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO...Baxter Healthcare CorporationFTM
Z-0664-2024Class IIPeri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X...Baxter Healthcare CorporationPSQ
Z-0663-2024Class IIBaxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL...Baxter Healthcare CorporationDXC
Z-0662-2024Class IIBaxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b)...Baxter Healthcare CorporationLMF
Z-0661-2024Class IIBaxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b)...Baxter Healthcare CorporationLMF
Z-0660-2024Class IIBaxter Preveleak Surgical Sealant, Product Codes: ADS201808Baxter Healthcare CorporationNBE
Z-0659-2024Class IIBaxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520...Baxter Healthcare CorporationDWP
Z-0658-2024Class IIBaxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G...Baxter Healthcare CorporationMTJ
Z-0657-2024Class IIBaxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072Baxter Healthcare CorporationNBE
Z-0656-2024Class IIBaxter Flo-Rester, Disposable internal vessel occluder, distributed in the following...Baxter Healthcare CorporationDXC
Z-0714-2024Class IIAmbu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2Ambu Inc.EOQ
Z-0730-2024Class IIUltrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section)...Oakworks IncLGX
Z-0729-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography...Oakworks IncLGX
Z-0728-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section)...Oakworks IncLGX
Z-0727-2024Class IIUltrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound...Oakworks IncLGX
Z-0692-2024Class IIModel No. CYF-V2R, VISERA Cysto-Nephro VideoscopeShirakawa Olympus Co., Ltd.FAJ
Z-0691-2024Class IIModel No. CYF-V2, VISERA Cysto-Nephro VideoscopeShirakawa Olympus Co., Ltd.FAJ
Z-0690-2024Class IIModel No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPEShirakawa Olympus Co., Ltd.FAJ
Z-0689-2024Class IIModel No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPEShirakawa Olympus Co., Ltd.FAJ
Z-1052-2024Class IDover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG...Medtronic, Inc.KOD
Z-0718-2024Class IISOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BSOLYMPUS Corporation of the AmericasGEX
Z-0717-2024Class IISoltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFCOLYMPUS Corporation of the AmericasGEX
Z-0716-2024Class IISoltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150...OLYMPUS Corporation of the AmericasGEX
Z-0688-2024Class IIModel No. ENF-XP, RHINO-LARYNGOFIBERSCOPEShirakawa Olympus Co., Ltd.EOB
Z-0687-2024Class IIModel No. BF-XP190, EVIS EXERA III BronchovideoscopeShirakawa Olympus Co., Ltd.EOQ
Z-0686-2024Class IIModel No. BF-P190, EVIS EXERA III BronchovideoscopeShirakawa Olympus Co., Ltd.EOQ
Z-0685-2024Class IIModel No. CYF-5R, CystonephrofiberscopeShirakawa Olympus Co., Ltd.FAJ
Z-0684-2024Class IIModel No. CYF-5, CystonephrofiberscopeShirakawa Olympus Co., Ltd.FAJ