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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 22 of 1581

Evidence Product Join Root cause
device-recall:cfres:181728 SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process. Official recall number · Z-2630-2020 Under Investigation by firm
device-recall:cfres:181931 BodyGuard Microset, REF: A100-163XSL Official recall number · Z-2574-2020 Device Design
device-recall:cfres:181946 BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV Official recall number · Z-2589-2020 Device Design
device-recall:cfres:190921 Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 Official recall number · Z-0501-2022 Process control
device-recall:cfres:190717 Senior Living Arial Emergency and Nurse Call Systems Official recall number · Z-0497-2022 Component design/selection
device-recall:cfres:191802 Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209 Official recall number · Z-0697-2022 Process design
device-recall:cfres:191615 LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 Official recall number · Z-0713-2022 Nonconforming Material/Component
device-recall:cfres:192055 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 Official recall number · Z-0684-2022 Labeling design
device-recall:cfres:191627 Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 Official recall number · Z-0645-2022 Under Investigation by firm
device-recall:cfres:191569 Zenition 50, Model #718096 Official recall number · Z-0647-2022 Under Investigation by firm
device-recall:cfres:191404 GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system. Official recall number · Z-0610-2022 Process control
device-recall:cfres:191272 Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 Official recall number · Z-0570-2022 Other
device-recall:cfres:192085 RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297 Official recall number · Z-0732-2022 Software design
device-recall:cfres:191860 JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Official recall number · Z-0766-2022 Packaging process control
device-recall:cfres:191831 HYDRATOME RX 44-20MM/260CM Material Number: M00583040 Official recall number · Z-0759-2022 Packaging process control
device-recall:cfres:191969 PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 Official recall number · Z-0744-2022 Packaging process control
device-recall:cfres:191829 DREAMTOME 49-30MM/260CM Material Number: M00584010 Official recall number · Z-0757-2022 Packaging process control
device-recall:cfres:192319 ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235 Official recall number · Z-0747-2022 Device Design
device-recall:cfres:191703 LINQ II Insertable Cardiac Monitor Official recall number · Z-0782-2022 Nonconforming Material/Component
device-recall:cfres:191238 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Official recall number · Z-0538-2022 Under Investigation by firm
device-recall:cfres:191370 KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls. Official recall number · Z-0543-2022 Labeling mix-ups
device-recall:cfres:191241 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Official recall number · Z-0541-2022 Under Investigation by firm
device-recall:cfres:191237 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Official recall number · Z-0537-2022 Under Investigation by firm
device-recall:cfres:191234 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Official recall number · Z-0534-2022 Under Investigation by firm
device-recall:cfres:190805 GE Vscan Extend, being sold as "Vscan Extend Dual USB" Official recall number · Z-0520-2022 Device Design

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