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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 25 of 1581

Evidence Product Join Root cause
device-recall:cfres:188104 Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component. Official recall number · Z-2132-2021 Unknown/Undetermined by firm
device-recall:cfres:187477 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980 Official recall number · Z-2103-2021 Mixed-up of materials/components
device-recall:cfres:187862 OxyMask O2 Adult REF OM-1125-14 Official recall number · Z-2141-2021 Nonconforming Material/Component
device-recall:cfres:184987 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. Official recall number · Z-0738-2021 Packaging change control
device-recall:cfres:184934 BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448609 Official recall number · Z-0764-2021 Nonconforming Material/Component
device-recall:cfres:184930 BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448607 Official recall number · Z-0760-2021 Nonconforming Material/Component
device-recall:cfres:184882 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091 Official recall number · Z-0789-2021 Process control
device-recall:cfres:185027 EXOGEN Ultrasound Coupling Gel Official recall number · Z-0810-2021 Nonconforming Material/Component
device-recall:cfres:184628 Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. Official recall number · Z-0783-2021 Process control
device-recall:cfres:184887 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118 Official recall number · Z-0794-2021 Process control
device-recall:cfres:182568 CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site). Official recall number · Z-0529-2021 Other
device-recall:cfres:184449 Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque. Official recall number · Z-0520-2021 Nonconforming Material/Component
device-recall:cfres:184407 Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Official recall number · Z-0534-2021 Device Design
device-recall:cfres:184462 The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler. Official recall number · Z-0513-2021 Software design
device-recall:cfres:184781 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone. Official recall number · Z-0626-2021 Process control
device-recall:cfres:184783 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. Official recall number · Z-0628-2021 Process control
device-recall:cfres:184365 DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S Official recall number · Z-0573-2021 Use error
device-recall:cfres:184368 DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S Official recall number · Z-0576-2021 Use error
device-recall:cfres:184537 IceRod" 1.5 MRI 90¿ Cryoablation Needle¿ Official recall number · Z-0678-2021 Under Investigation by firm
device-recall:cfres:184518 IceRod" 1.5 CX 90¿ Cryoablation Needle¿ Official recall number · Z-0663-2021 Under Investigation by firm
device-recall:cfres:184513 IceFORCE" 2.1 CX Cryoablation Needle Official recall number · Z-0658-2021 Under Investigation by firm
device-recall:cfres:184545 IcePearl" 2.1 CX Prostate Cryoablation Kit Official recall number · Z-0683-2021 Under Investigation by firm
device-recall:cfres:184524 IceRod" 1.5 i-Thaw" Cryoablation Needle Official recall number · Z-0665-2021 Under Investigation by firm
device-recall:cfres:183730 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286 Official recall number · Z-0705-2021 Process control
device-recall:cfres:184517 IcePearl" 2.1 CX L 90¿ Cryoablation Needle Official recall number · Z-0662-2021 Under Investigation by firm

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