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Recall Observatory FDA recall evidence

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Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1546 of 1581

Evidence Product Join Root cause
device-recall:cfres:139497 KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway. Official recall number · Z-2504-2015 Process control
device-recall:cfres:139068 LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Official recall number · Z-2688-2015 Packaging
device-recall:cfres:138900 E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Official recall number · Z-2587-2015 Packaging
device-recall:cfres:139493 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway. Official recall number · Z-2500-2015 Process control
device-recall:cfres:139591 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter Official recall number · Z-2732-2015 Unknown/Undetermined by firm
device-recall:cfres:138930 LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Official recall number · Z-2594-2015 Packaging
device-recall:cfres:139462 MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC Official recall number · Z-2546-2015 Process control
device-recall:cfres:139267 Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems Official recall number · Z-2491-2015 Software design
device-recall:cfres:139042 TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Official recall number · Z-2665-2015 Packaging
device-recall:cfres:139390 IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis. Official recall number · Z-2423-2015 Packaging process control
device-recall:cfres:138851 Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Official recall number · Z-2415-2015 Other
device-recall:cfres:139141 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. Official recall number · Z-2452-2015 Nonconforming Material/Component
device-recall:cfres:138722 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component. Official recall number · Z-2360-2015 Under Investigation by firm
device-recall:cfres:138328 Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children. Official recall number · Z-2272-2015 Process control
device-recall:cfres:137092 ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium. Official recall number · Z-2307-2015 Device Design
device-recall:cfres:137105 ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium. Official recall number · Z-2312-2015 Device Design
device-recall:cfres:137083 ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium. Official recall number · Z-2304-2015 Device Design
device-recall:cfres:138501 Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures. Official recall number · Z-2276-2015 No Marketing Application
device-recall:cfres:136261 Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question. Official recall number · Z-2056-2015 Labeling design
device-recall:cfres:137821 Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar. Official recall number · Z-1986-2015 Device Design
device-recall:cfres:137281 Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery Official recall number · Z-2000-2015 Nonconforming Material/Component
device-recall:cfres:137431 Podiatry Pack - contains Devon Light Glove Used during surgery Official recall number · Z-2029-2015 Nonconforming Material/Component
device-recall:cfres:137445 Upper Extremity Pack - contains Devon Light Glove Used during surgery Official recall number · Z-2042-2015 Nonconforming Material/Component
device-recall:cfres:137375 Suction Pack - contains Devon Light Glove Used during surgery Official recall number · Z-2011-2015 Nonconforming Material/Component
device-recall:cfres:137437 Pediatric Pack - contains Devon Light Glove Used during surgery Official recall number · Z-2034-2015 Nonconforming Material/Component

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