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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 1531 of 1581

Evidence Product Join Root cause
device-recall:cfres:172315 Drill, cannulated, 3x90mm, AO, Item Number ST502015631 Official recall number · Z-1482-2019 Under Investigation by firm
device-recall:cfres:172312 Drill, cannulated, 2x95mm, AO, Item Number ST502015623 Official recall number · Z-1479-2019 Under Investigation by firm
device-recall:cfres:172629 NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. Official recall number · Z-1280-2019 Software design
device-recall:cfres:172281 V-TEK", micro-countersink, round shaft, Item Number 28.66.112 Official recall number · Z-1464-2019 Under Investigation by firm
device-recall:cfres:172274 CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351 Official recall number · Z-1457-2019 Under Investigation by firm
device-recall:cfres:171641 EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor). Official recall number · Z-1193-2019 Use error
device-recall:cfres:172305 Drill, 2.7x125mm, AO , Item Number ST502015217 Official recall number · Z-1473-2019 Under Investigation by firm
device-recall:cfres:172336 Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically. Official recall number · Z-1390-2019 Under Investigation by firm
device-recall:cfres:172340 Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Official recall number · Z-1379-2019 Under Investigation by firm
device-recall:cfres:171369 Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 Official recall number · Z-1371-2019 Device Design
device-recall:cfres:172319 Drill, contra-angle, 1.5x85mm, Item Number ST502015706 Official recall number · Z-1486-2019 Under Investigation by firm
device-recall:cfres:172402 AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. Official recall number · Z-1397-2019 Component design/selection
device-recall:cfres:172240 Drill, 2.5x135mm, AO, Item Number 502015142 Official recall number · Z-1423-2019 Under Investigation by firm
device-recall:cfres:172011 McKesson Cardiology Hemo Official recall number · Z-1490-2019 Software Design Change
device-recall:cfres:172277 CBS micro, countersink, cannulated, AO, Item Number 503004541 Official recall number · Z-1460-2019 Under Investigation by firm
device-recall:cfres:161604 Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter. Official recall number · Z-1308-2018 Process control
device-recall:cfres:161078 HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Official recall number · Z-1316-2018 Software Manufacturing/Software Deployment
device-recall:cfres:161833 ArrowClarke" PleuraSeal¿ Thoracentesis Kit Official recall number · Z-1298-2018 Component design/selection
device-recall:cfres:163903 EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses. Official recall number · Z-1527-2018 Nonconforming Material/Component
device-recall:cfres:163236 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults. Official recall number · Z-1526-2018 Labeling mix-ups
device-recall:cfres:162740 Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. Official recall number · Z-1520-2018 Nonconforming Material/Component
device-recall:cfres:162621 Alere iScreen Dx Urine Drug Screen Card Official recall number · Z-1542-2018 Labeling Change Control
device-recall:cfres:162686 Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled. Official recall number · Z-1368-2018 Employee error
device-recall:cfres:162481 ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 Official recall number · Z-1364-2018 Nonconforming Material/Component
device-recall:cfres:163146 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. Official recall number · Z-1377-2018 Device Design

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