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Sources: EU EUDAMED, US FDA
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Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXC·February 22, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXC·February 22, 2024
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DXC·February 22, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA Recall
Open, Classified
·SURGICAL SPECIALTIES·Product code GAM·March 26, 2024
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
FDA Recall
Open, Classified
·Carefree Surgical Specialties·Product code GDY·July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
FDA Recall
Open, Classified
·Carefree Surgical Specialties·Product code GDY·July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
FDA Recall
Open, Classified
·Carefree Surgical Specialties·Product code GDY·July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
FDA Recall
Open, Classified
·Carefree Surgical Specialties·Product code GDY·July 1, 2025
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
FDA Recall
Open, Classified
·SSC- Surgical Specialties Corporation·Product code HNN·April 23, 2026
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Recall
Open, Classified
·3M Company Health Care Business 3m Center·Product code LWK·January 12, 2024
3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Recall
Open, Classified
·3M Company Health Care Business 3m Center·Product code LWK·January 12, 2024
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 7, 2024
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 7, 2024
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0544CJDA
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 7, 2024
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
FDA Recall
Open, Classified
·Covidien Llc·Product code GCI·May 12, 2020
Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
FDA Recall
Open, Classified
·Covidien Llc·Product code GCI·May 12, 2020
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL
FDA Recall
Open, Classified
·Alcon Research, LLC·Product code LRO·March 15, 2024
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
FDA Recall
Open, Classified
·Covidien Llc·Product code GCI·May 12, 2020
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
FDA Recall
Open, Classified
·Covidien Llc·Product code GCI·May 12, 2020
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code LRO·August 16, 2023