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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 1499 of 1581

Evidence Product Join Root cause
device-recall:cfres:192940 EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery. Official recall number · Z-1081-2022 Device Design
device-recall:cfres:192784 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) Official recall number · Z-1055-2022 Under Investigation by firm
device-recall:cfres:192844 Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325 mg), Product Code: L202L. Official recall number · Z-1089-2022 Process control
device-recall:cfres:193357 MicroScan WalkAway-40 plus Instrument REF B1018-283 Official recall number · Z-1083-2022 Mixed-up of materials/components
device-recall:cfres:192780 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US Official recall number · Z-1062-2022 Under Investigation by firm
device-recall:cfres:192303 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System Official recall number · Z-0858-2022 Device Design
device-recall:cfres:192305 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System Official recall number · Z-0860-2022 Device Design
device-recall:cfres:192882 iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 Official recall number · Z-0899-2022 Nonconforming Material/Component
device-recall:cfres:191972 Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL Official recall number · Z-0889-2022 Device Design
device-recall:cfres:193280 Single Shot Epidural Tray Catalog 1165 Official recall number · Z-1151-2022 Other
device-recall:cfres:193095 Percept BrainSense Implantable Neurostimulator (INS), Model B35200 Official recall number · Z-1128-2022 Under Investigation by firm
device-recall:cfres:193248 Locking Cap for PD Catheter Adapter Official recall number · Z-1142-2022 No Marketing Application
device-recall:cfres:192691 Puritan Bennett 980 Series Ventilator Official recall number · Z-0966-2022 Under Investigation by firm
device-recall:cfres:192324 da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460 Official recall number · Z-0999-2022 Under Investigation by firm
device-recall:cfres:192675 Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300 Official recall number · Z-0961-2022 Under Investigation by firm
device-recall:cfres:192698 Artis zee biplane MN, Model Number 10094143 Official recall number · Z-0972-2022 Device Design
device-recall:cfres:192701 Artis Q ceiling, Model Number 10848281 Official recall number · Z-0975-2022 Device Design
device-recall:cfres:192649 ORAcollect RNA: ORE-100 Official recall number · Z-0982-2022 Nonconforming Material/Component
device-recall:cfres:190644 Regard, T AND A - Rogers, sterilized convenience kits Official recall number · Z-0469-2022 Error in labeling
device-recall:cfres:192369 Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) Official recall number · Z-0827-2022 Component design/selection
device-recall:cfres:191371 KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. Official recall number · Z-0544-2022 Labeling mix-ups
device-recall:cfres:190927 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Official recall number · Z-0553-2022 Nonconforming Material/Component
device-recall:cfres:191527 IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Official recall number · Z-0661-2022 Process change control
device-recall:cfres:191732 meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis. Official recall number · Z-0678-2022 Storage
device-recall:cfres:191731 Philips Respironics V60 Plus Ventilator Part Number 1138747 Official recall number · Z-0663-2022 Process control

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