Olympus Corporation of the Americas - Thunderbeat - Class 2 Recall
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 13, 2023 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Thunderbeat - Class 2 Recall
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 13, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Sterile Procedural Trays - Class 2 Recall
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. ...
Source: Medical Device Recalls - February 7, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Sterile Procedural Trays - Class 2 Recall
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGAT...
Source: Medical Device Recalls - February 7, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Sterile Procedural Trays - Class 2 Recall
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 7, 2023 Category: Medical Devices Source Type: alerts
American Contract Systems, Inc. - Various hysterectomy, vaginal packs - Class 2 Recall
Various hysterectomy, vaginal packs (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2022 Category: Medical Devices Source Type: alerts
Medline Industries Inc - Medline convenience kits containing - Class 2 Recall
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DY...
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Medline Industries Inc (Northpoint Services) - Antifog solution - Class 2 Recall
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPA...
Source: Medical Device Recalls - July 19, 2019 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - Advincula Delineator - Class 2 Recall
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2019 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - Advincula Delineator - Class 2 Recall
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 16, 2019 Category: Medical Devices Source Type: alerts
Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2017 Category: Medical Equipment Source Type: alerts
Resource Optimization & Innovation Llc - Sterile, GY0485 Robotic Hysterectomy Pkg surgical kit - Class 2 Recall
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2015 Category: Medical Equipment Source Type: alerts
