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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 1521 of 1581

Evidence Product Join Root cause
device-recall:cfres:175474 Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures. Official recall number · Z-2366-2019 Vendor change control
device-recall:cfres:175099 Kit BD Max StaphSR; Catalog # 443418 Official recall number · Z-2332-2019 Process control
device-recall:cfres:175147 Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 Official recall number · Z-2361-2019 Under Investigation by firm
device-recall:cfres:175058 ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Official recall number · Z-2351-2019 Software design
device-recall:cfres:174676 ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Official recall number · Z-2320-2019 Software design
device-recall:cfres:174653 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246 Official recall number · Z-2225-2019 Other
device-recall:cfres:173665 SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use Official recall number · Z-2709-2019 Component design/selection
device-recall:cfres:176328 TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 Official recall number · Z-0034-2020 Nonconforming Material/Component
device-recall:cfres:173712 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use Official recall number · Z-2750-2019 Component design/selection
device-recall:cfres:176200 STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture Official recall number · Z-0048-2020 Under Investigation by firm
device-recall:cfres:172093 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use Official recall number · Z-2600-2019 Component design/selection
device-recall:cfres:173502 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use Official recall number · Z-2618-2019 Component design/selection
device-recall:cfres:175288 Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850 Official recall number · Z-0017-2020 Process control
device-recall:cfres:176402 SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures. Official recall number · Z-0006-2020 Process control
device-recall:cfres:173631 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use Official recall number · Z-2682-2019 Component design/selection
device-recall:cfres:176330 TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 Official recall number · Z-0036-2020 Nonconforming Material/Component
device-recall:cfres:173635 SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use Official recall number · Z-2684-2019 Component design/selection
device-recall:cfres:173524 SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for cardiovascular use Official recall number · Z-2636-2019 Component design/selection
device-recall:cfres:173505 SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use Official recall number · Z-2621-2019 Component design/selection
device-recall:cfres:172089 SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular use Official recall number · Z-2596-2019 Component design/selection
device-recall:cfres:176306 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580 Official recall number · Z-0027-2020 Error in labeling
device-recall:cfres:173519 SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use Official recall number · Z-2632-2019 Component design/selection
device-recall:cfres:176331 TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 Official recall number · Z-0037-2020 Nonconforming Material/Component
device-recall:cfres:172084 SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use Official recall number · Z-2592-2019 Component design/selection
device-recall:cfres:173588 SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use Official recall number · Z-2659-2019 Component design/selection

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