ROi CPS LLC - Regard - Class 2 Recall
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO,...
Source: Medical Device Recalls - December 29, 2020 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

Olympus Corporation of the Americas - Olympus MAJ209 SingleUse Suction Valve (MAJ209) - Class 2 Recall
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2019 Category: Medical Devices Source Type: alerts

Dornier Medtech America, Inc. - Class 2 Recall
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fib...
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts

Philips North America, LLC - Urodiagnost - Class 2 Recall
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2019 Category: Medical Devices Source Type: alerts

Pentax of America Inc - Video Cystoscope models ECY1570 and ECY1570K - Class 2 Recall
Video Cystoscope models ECY-1570 and ECY-1570K (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Pentax Medical Company - Class 2 Recall
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 29, 2016 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 2 Recall
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts

Customed, Inc - CYSTOSCOPY III - Class 2 Recall
(1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2015 Category: Medical Equipment Source Type: alerts

Customed, Inc - Cystoscopy Pack III - Class 1 Recall
Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F EO sterilized s...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Customed, Inc - Class 1 Recall
CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 30" X 42" (1) DRAPE CYSTOSCOPY T 60" X 87" 35" SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts

Hospira Inc. - CYSTOSCOPY/IRRIGATION SET - Class 2 Recall
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2014 Category: Medical Equipment Source Type: alerts