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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 64 of 1581

Evidence Product Join Root cause
device-recall:cfres:198615 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S Official recall number · Z-1248-2023 Under Investigation by firm
device-recall:cfres:198325 CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment. Official recall number · Z-1225-2023 Device Design
device-recall:cfres:197252 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Official recall number · Z-0740-2023 Under Investigation by firm
device-recall:cfres:197273 Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis. Official recall number · Z-0761-2023 Process change control
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:196969 DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 Official recall number · Z-0654-2023 Nonconforming Material/Component
device-recall:cfres:196944 DeRoyal KIT HEART B PACK, REF 89-9042.07 Official recall number · Z-0629-2023 Nonconforming Material/Component
device-recall:cfres:196923 DeRoyal HEART PACK, REF 89-8351.12 Official recall number · Z-0609-2023 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:196742 Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST Official recall number · Z-0333-2023 Process control
device-recall:cfres:196704 Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer Official recall number · Z-0352-2023 Process design
device-recall:cfres:196696 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900) Official recall number · Z-0422-2023 Component design/selection
device-recall:cfres:197249 Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system Official recall number · Z-0476-2023 Process control
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

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