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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 46 of 1581

Evidence Product Join Root cause
device-recall:cfres:205402 Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT Official recall number · Z-0844-2024 Process control
device-recall:cfres:205131 SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 Official recall number · Z-0871-2024 Nonconforming Material/Component
device-recall:cfres:205328 MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A Official recall number · Z-0964-2024 Error in labeling
device-recall:cfres:200518 ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators Official recall number · Z-1711-2023 Under Investigation by firm
device-recall:cfres:199957 MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. Official recall number · Z-1977-2023 Software Manufacturing/Software Deployment
device-recall:cfres:199976 bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator Official recall number · Z-1967-2023 Nonconforming Material/Component
device-recall:cfres:200579 CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators Official recall number · Z-1762-2023 Under Investigation by firm
device-recall:cfres:199910 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Official recall number · Z-1907-2023 Under Investigation by firm
device-recall:cfres:200191 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only Official recall number · Z-1908-2023 Process control
device-recall:cfres:200542 CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators Official recall number · Z-1731-2023 Under Investigation by firm
device-recall:cfres:200525 ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators Official recall number · Z-1717-2023 Under Investigation by firm
device-recall:cfres:200628 ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators Official recall number · Z-1801-2023 Under Investigation by firm
device-recall:cfres:200603 CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators Official recall number · Z-1781-2023 Under Investigation by firm
device-recall:cfres:211913 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper Official recall number · Z-1176-2025 Device Design
device-recall:cfres:211997 Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062 Official recall number · Z-1070-2025 Device Design
device-recall:cfres:211908 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No Official recall number · Z-1014-2025 Process control
device-recall:cfres:211907 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No Official recall number · Z-1013-2025 Process control
device-recall:cfres:211624 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400). Official recall number · Z-0998-2025 Under Investigation by firm
device-recall:cfres:211621 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400). Official recall number · Z-0996-2025 Under Investigation by firm
device-recall:cfres:212569 Brivo MR355, NMRI system Official recall number · Z-1240-2025 Software design
device-recall:cfres:212434 Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells. Official recall number · Z-1249-2025 Unknown/Undetermined by firm
device-recall:cfres:211985 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems Official recall number · Z-1112-2025 Under Investigation by firm
device-recall:cfres:212047 Azurion 3 M12 System Code: (1) 722063 (2) 722221 Official recall number · Z-1087-2025 Device Design
device-recall:cfres:212080 PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures. Official recall number · Z-1097-2025 Process control
device-recall:cfres:212042 AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 Official recall number · Z-1082-2025 Device Design

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