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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 70 of 1581

Evidence Product Join Root cause
device-recall:cfres:190389 DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US, Official recall number · Z-0825-2022 Labeling design
device-recall:cfres:192298 NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250 Official recall number · Z-0823-2022 Under Investigation by firm
device-recall:cfres:192167 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A Official recall number · Z-0814-2022 Under Investigation by firm
device-recall:cfres:193088 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Official recall number · Z-1066-2022 Under Investigation by firm
device-recall:cfres:193361 MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R Official recall number · Z-1087-2022 Mixed-up of materials/components
device-recall:cfres:192967 Regard brand CABG Pack A and B - Spartanburg Official recall number · Z-1051-2022 Under Investigation by firm
device-recall:cfres:192681 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379. Product Code/UDI /Description: 85320 650862853209 Advanta V12 Covered Stent, 5mm x 38mm x 80cm; 85321 650862853216 Advanta V12 Covered Stent, 5mm x 59mm x 80cm; 85322 650862853223 Advanta V12 Covered Stent, 6mm x 38mm x 80cm; 85323 650862853230 Advanta V12 Covered Stent, 6mm x 59mm x 80cm 85324 650862853247 Advanta V12 Covered Stent, 7mm x 38mm x 80cm; 85325 650862853254 Advanta V12 Covered Stent, 7mm x 59mm x 80cm; 85326 650862853261 Advanta V12 Covered Stent, 8mm x 38mm x 80cm; 85327 650862853278 Advanta V12 Covered Stent, 8mm x 59mm x 80cm; 85328 650862853285 Advanta V12 Covered Stent, 9mm x 38mm x 80cm; 85329 650862853292 Advanta V12 Covered Stent, 9mm x 59mm x 80cm; 85330 650862853308 Advanta V12 Covered Stent, 5mm x 38mm x120cm; 85331 650862853315 Advanta V12 Covered Stent, 5mm x 59mm x120cm; 85332 650862853322 Advanta V12 Covered Stent, 6mm x 38mm x120cm; 85333 650862853339 Advanta V12 Covered Stent, 6mm x 59mm x120cm; 85334 650862853346 Advanta V12 Covered Stent, 7mm x 38mm x120cm; 85335 650862853353 Advanta V12 Covered Stent, 7mm x 59mm x120cm; 85336 650862853360 Advanta V12 Covered Stent, 8mm x 38mm x120cm; 85337 650862853377 Advanta V12 Covered Stent, 8mm x 59mm x120cm; 85338 650862853384 Advanta V12 Covered Stent, 9mm x 38mm x120cm; 85339 650862853391 Advanta V12 Covered Stent, 9mm x 59mm x120cm; 85340 650862853407 Advanta V12 Covered Stent, 5mm x 16mm x 80cm; 85341 650862853414 Advanta V12 Covered Stent, 5mm x 22mm x 80cm; 85342 650862853421 Advanta V12 Covered Stent, 6mm x 16mm x 80cm; 85343 650862853438 Advanta V12 Covered Stent, 6mm x 22mm x 80cm; 85344 650862853445 Advanta V12 Covered Stent, 7mm x 16mm x 80cm; 85345 650862853452 Advanta V12 Covered Stent, 7mm x 22mm x 80cm; 85350 650862853506 Advanta V12 Covered Stent, 5mm x 16mm x 120cm; 85351 650862853513 Advanta V12 Covered Stent, 5mm x 22mm x 120cm; 85352 650862853520 Advanta V12 Covered Stent, 6mm x 16mm x 120cm; 85353 650862853537 Advanta V12 Covered Stent, 6mm x 22mm x 120cm; 85354 650862853544 Advanta V12 Covered Stent, 7mm x 16mm x 120cm; 85355 650862853551 Advanta V12 Covered Stent, 7mm x 22mm x 120cm; 85360 650862853605 Advanta V12 Covered Stent, 10mm x 38mm x 80cm; 85361 650862853612 Advanta V12 Covered Stent, 10mm x 59mm x 80cm; 85364 650862853643 Advanta V12 Covered Stent, 10mm x 38mm x 120cm; 85365 650862853650 Advanta V12 Covered Stent, 10mm x 59mm x 120cm; 85370 650862853704 Advanta V12 Large Diameter, 12mm x 29mm x 80cm; 85371 650862853711 Advanta V12 Large Diameter, 12mm x 41mm x 80cm; 85372 650862853728 Advanta V12 Large Diameter, 12mm x 61mm x 80cm; 85379 650862853797 Advanta V12 Large Diameter, 12mm x 29mm x 120cm; 85388 650862853889 Advanta V12 Covered Stent, 5mm x 32mm x 80cm; ;85390 650862853902 Advanta V12 Covered Stent, 7mm x 32mm x 80cm; 85391 650862853919 Advanta V12 Covered Stent, 8mm x 32mm x 80cm; 85392 650862853926 Advanta V12 Covered Stent, 9mm x 32mm x 80cm; 85394 650862853940 Advanta V12 Covered Stent, 5mm x 32mm x 120cm; 85395 650862853957 Advanta V12 Covered Stent, 6mm x 32mm x 120cm. 85396 650862853964 Advanta V12 Covered Stent, 7mm x 32mm x 120cm 85397 650862853971 Advanta V12 Covered Stent, 8mm x 32mm x 120cm 85398 650862853988 Advanta V12 Covered Stent, 9mm x 32mm x 120cm Official recall number · Z-1076-2022 Device Design
device-recall:cfres:192990 Sara Plus Active Floor Lift Official recall number · Z-1098-2022 Device Design
device-recall:cfres:193222 VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. Official recall number · Z-1108-2022 Process control
device-recall:cfres:192226 Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 Official recall number · Z-0838-2022 Other
device-recall:cfres:190590 BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use Official recall number · Z-0845-2022 Labeling Change Control
device-recall:cfres:192281 Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Official recall number · Z-0832-2022 Employee error
device-recall:cfres:192469 RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29 Official recall number · Z-0849-2022 Device Design
device-recall:cfres:192098 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 Official recall number · Z-0828-2022 Nonconforming Material/Component
device-recall:cfres:192304 SIGNA Excite 3T. Magnetic Resonance Imaging System Official recall number · Z-0859-2022 Device Design
device-recall:cfres:192375 Revolution CT, Revolution CT ES Official recall number · Z-0816-2022 Radiation Control for Health and Safety Act
device-recall:cfres:192367 Alinity m HBV Application Specification File (US and CE) Official recall number · Z-0883-2022 Under Investigation by firm
device-recall:cfres:192684 Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Official recall number · Z-0877-2022 Component change control
device-recall:cfres:192031 MODEL: X-RAY TV SYSTEM SONIALVISION G4 Official recall number · Z-0868-2022 Software design
device-recall:cfres:192184 First SIGN SARS-CoV-2 Antigen Test Official recall number · Z-0892-2022 No Marketing Application
device-recall:cfres:192331 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Official recall number · Z-0930-2022 Device Design
device-recall:cfres:192384 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument Official recall number · Z-0913-2022 Nonconforming Material/Component
device-recall:cfres:192208 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package. Official recall number · Z-0948-2022 Mixed-up of materials/components
device-recall:cfres:192329 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Official recall number · Z-0928-2022 Device Design
device-recall:cfres:192565 CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US Official recall number · Z-0936-2022 Device Design

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