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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 1519 of 1581

Evidence Product Join Root cause
device-recall:cfres:176717 Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system. Official recall number · Z-0219-2020 Nonconforming Material/Component
device-recall:cfres:176776 MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm Official recall number · Z-0212-2020 Labeling mix-ups
device-recall:cfres:172029 Rifton E-Pacer, SKU K660, powered lift device Official recall number · Z-0166-2020 Nonconforming Material/Component
device-recall:cfres:174203 Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap. Official recall number · Z-0179-2020 Packaging
device-recall:cfres:176875 Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700 Official recall number · Z-0329-2020 Packaging change control
device-recall:cfres:176878 NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107 Official recall number · Z-0332-2020 Packaging change control
device-recall:cfres:176833 Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 47492801802 47492801813 47492801902 47492802002 47492802013 47493600313 47493600403 47493600407 47493600413 47493600503 47493600507 47493600513 47493600603 47493600607 47493600613 47493600703 47493600707 47493600713 47493600803 47493600807 47493600813 47493600907 47493600913 47493601003 47493601007 47493601013 47493601113 47493601203 47493601207 47493601213 47493601313 47493601403 47493601407 47493601413 47493601513 47493601607 47493601613 47493601813 47493602007 47493602013 47493602213 47493603305 47493603306 47493603405 47493603406 47493603504 47493604604 47493800303 47493800402 47493800502 47493800603 47493800613 47493800702 47493800703 47493800802 47493800803 47493800902 47494600403 47494600407 47494600413 47494600503 47494600507 47494600513 47494600603 47494600607 47494600613 47494600703 47494600707 47494600713 47494600803 47494600807 47494600813 47494600913 47494601003 47494601013 47494601113 47494601203 47494601213 47494603305 47494603306 47494603405 47494603406 47494603504 47494604604 Official recall number · Z-0312-2020 Packaging change control
device-recall:cfres:175307 Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. Official recall number · Z-0417-2020 Labeling False and Misleading
device-recall:cfres:177225 HeartStart XL+ Defibrillator/Monitor, Model 861290 Official recall number · Z-0498-2020 Process control
device-recall:cfres:177342 Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques. Official recall number · Z-0450-2020 Process change control
device-recall:cfres:177352 Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques. Official recall number · Z-0460-2020 Process change control
device-recall:cfres:177235 MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 Official recall number · Z-0494-2020 Under Investigation by firm
device-recall:cfres:176437 BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices. Official recall number · Z-0530-2020 Environmental control
device-recall:cfres:176962 ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075 Official recall number · Z-0382-2020 Device Design
device-recall:cfres:177385 Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography. Official recall number · Z-0360-2020 Error in labeling
device-recall:cfres:177052 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use. Official recall number · Z-0361-2020 Error in labeling
device-recall:cfres:176960 ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603 Official recall number · Z-0380-2020 Device Design
device-recall:cfres:176904 TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization. Official recall number · Z-0366-2020 Employee error
device-recall:cfres:174933 YNHH SCOPE KIT Kit Code: MNS10475 Official recall number · Z-0408-2020 Material/Component Contamination
device-recall:cfres:177059 Randox Liquid Cardiac Controls Catalogue Number CQ5052. Official recall number · Z-0413-2020 Under Investigation by firm
device-recall:cfres:176992 ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 Official recall number · Z-0403-2020 Device Design
device-recall:cfres:176976 ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 Official recall number · Z-0393-2020 Device Design
device-recall:cfres:177122 Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 Official recall number · Z-0411-2020 Under Investigation by firm
device-recall:cfres:176577 Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use Official recall number · Z-0365-2020 Under Investigation by firm
device-recall:cfres:176096 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes Official recall number · Z-0072-2020 Under Investigation by firm

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