Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:188137
- Product
- Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
- Join
- Official recall number ·
Z-2169-2021 - Root cause
- Process design
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- Evidence
- device-recall:cfres:188130
- Product
- ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
- Join
- Official recall number ·
Z-2142-2021 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:187877
- Product
- FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- Join
- Official recall number ·
Z-2153-2021 - Root cause
- Equipment maintenance
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- Evidence
- device-recall:cfres:187868
- Product
- AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Join
- Official recall number ·
Z-2144-2021 - Root cause
- Equipment maintenance
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- Evidence
- device-recall:cfres:188125
- Product
- OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
- Join
- Official recall number ·
Z-2160-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:188237
- Product
- Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
- Join
- Official recall number ·
Z-2367-2021 - Root cause
- Labeling design
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- Evidence
- device-recall:cfres:188429
- Product
- BD" Mouse IgG2a Isotype Control APC X39 ASR
- Join
- Official recall number ·
Z-2333-2021 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:188568
- Product
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Join
- Official recall number ·
Z-2384-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:188499
- Product
- Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
- Join
- Official recall number ·
Z-2353-2021 - Root cause
- Package design/selection
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- Evidence
- device-recall:cfres:188595
- Product
- ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
- Join
- Official recall number ·
Z-2348-2021 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:188696
- Product
- BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
- Join
- Official recall number ·
Z-2465-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:188128
- Product
- BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
- Join
- Official recall number ·
Z-2455-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:188753
- Product
- Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
- Join
- Official recall number ·
Z-2388-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:188619
- Product
- Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests
- Join
- Official recall number ·
Z-2409-2021 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:188802
- Product
- Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
- Join
- Official recall number ·
Z-2418-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:188786
- Product
- SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
- Join
- Official recall number ·
Z-2415-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:188626
- Product
- Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
- Join
- Official recall number ·
Z-2424-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:188240
- Product
- ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
- Join
- Official recall number ·
Z-2255-2021 - Root cause
- Other
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- Evidence
- device-recall:cfres:188352
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
- Join
- Official recall number ·
Z-2274-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:188353
- Product
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
- Join
- Official recall number ·
Z-2275-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:188172
- Product
- Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
- Join
- Official recall number ·
Z-2294-2021 - Root cause
- Software design
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- Evidence
- device-recall:cfres:188388
- Product
- Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
- Join
- Official recall number ·
Z-2276-2021 - Root cause
- Software design
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- Evidence
- device-recall:cfres:188102
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
- Join
- Official recall number ·
Z-2130-2021 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:188003
- Product
- Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
- Join
- Official recall number ·
Z-2091-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:188092
- Product
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
- Join
- Official recall number ·
Z-2120-2021 - Root cause
- Unknown/Undetermined by firm