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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 8 of 1581

Evidence Product Join Root cause
device-recall:cfres:189571 VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 Official recall number · Z-0425-2022 Nonconforming Material/Component
device-recall:cfres:190199 VIDAS FSH, REF 30407-01 Official recall number · Z-0434-2022 Nonconforming Material/Component
device-recall:cfres:189632 SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree. Official recall number · Z-0216-2022 Process control
device-recall:cfres:190052 HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. Official recall number · Z-0276-2022 Under Investigation by firm
device-recall:cfres:190138 Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355 Official recall number · Z-0305-2022 Software design
device-recall:cfres:190228 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 Official recall number · Z-0313-2022 Under Investigation by firm
device-recall:cfres:190058 BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to Official recall number · Z-0312-2022 Material/Component Contamination
device-recall:cfres:190088 Total Thyroxine (T4) ELISA; REF EIA-1781 Official recall number · Z-0310-2022 Nonconforming Material/Component
device-recall:cfres:190239 RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 Official recall number · Z-0328-2022 Under Investigation by firm
device-recall:cfres:189974 VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX Official recall number · Z-0396-2022 Device Design
device-recall:cfres:189879 BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma Official recall number · Z-0235-2022 Nonconforming Material/Component
device-recall:cfres:188749 REGARD Ultrasound Tray Official recall number · Z-0255-2022 Nonconforming Material/Component
device-recall:cfres:189934 Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004. Official recall number · Z-0244-2022 Nonconforming Material/Component
device-recall:cfres:190462 Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. Official recall number · Z-0393-2022 Under Investigation by firm
device-recall:cfres:190422 Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Official recall number · Z-0388-2022 Process control
device-recall:cfres:190571 DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile Official recall number · Z-0453-2022 Device Design
device-recall:cfres:190755 Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport. Official recall number · Z-0467-2022 Process design
device-recall:cfres:190407 Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP Official recall number · Z-0447-2022 Software design
device-recall:cfres:190586 BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095 Official recall number · Z-0356-2022 Device Design
device-recall:cfres:190193 Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Official recall number · Z-0351-2022 Reprocessing Controls
device-recall:cfres:190279 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 Official recall number · Z-0376-2022 Process control
device-recall:cfres:190273 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 Official recall number · Z-0370-2022 Process control
device-recall:cfres:185978 Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells. Official recall number · Z-1345-2021 Under Investigation by firm
device-recall:cfres:185799 PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Official recall number · Z-1137-2021 Under Investigation by firm
device-recall:cfres:185278 Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient. Official recall number · Z-1111-2021 Process control

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