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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 13 of 1581

Evidence Product Join Root cause
device-recall:cfres:196587 NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 Official recall number · Z-0223-2023 Under Investigation by firm
device-recall:cfres:196289 CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST Official recall number · Z-0212-2023 Under Investigation by firm
device-recall:cfres:196484 TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F.. Official recall number · Z-0228-2023 Process design
device-recall:cfres:196431 ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400 Official recall number · Z-0226-2023 Under Investigation by firm
device-recall:cfres:197080 BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 Official recall number · Z-0807-2023 Storage
device-recall:cfres:197133 ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 Official recall number · Z-0849-2023 Storage
device-recall:cfres:197149 VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 Official recall number · Z-0865-2023 Storage
device-recall:cfres:197302 Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium Official recall number · Z-0921-2023 Under Investigation by firm
device-recall:cfres:197159 PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR Official recall number · Z-0875-2023 Storage
device-recall:cfres:197060 VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341 Official recall number · Z-0787-2023 Storage
device-recall:cfres:197401 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C Official recall number · Z-0913-2023 Under Investigation by firm
device-recall:cfres:197137 VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 Official recall number · Z-0853-2023 Storage
device-recall:cfres:197076 PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851 Official recall number · Z-0803-2023 Storage
device-recall:cfres:197122 ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 Official recall number · Z-0841-2023 Storage
device-recall:cfres:197246 VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001 Official recall number · Z-0907-2023 Process design
device-recall:cfres:197366 Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 Official recall number · Z-0909-2023 Process control
device-recall:cfres:197117 VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 Official recall number · Z-0836-2023 Storage
device-recall:cfres:197384 DeRoyal Tonsillectomy Tray, REF 89-10698.01 Official recall number · Z-0906-2023 Nonconforming Material/Component
device-recall:cfres:197226 GEO-MED CATARACT PACK, REF 89-5790.08 Official recall number · Z-0709-2023 Nonconforming Material/Component
device-recall:cfres:196851 STRADIS HEALTHCARE, Endo Pack, Item No.682-509, Official recall number · Z-0550-2023 Packaging process control
device-recall:cfres:196960 DeRoyal TOTAL KNEE PACK, REF 89-9300.08 Official recall number · Z-0645-2023 Nonconforming Material/Component
device-recall:cfres:196793 Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray Official recall number · Z-0492-2023 Packaging process control
device-recall:cfres:196901 DeRoyal TRANS CANAL PACK, REF 89-7157.12 Official recall number · Z-0587-2023 Nonconforming Material/Component
device-recall:cfres:196984 DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02 Official recall number · Z-0669-2023 Nonconforming Material/Component
device-recall:cfres:196981 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04 Official recall number · Z-0666-2023 Nonconforming Material/Component

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