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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
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
FDA Recall
Terminated
·SSC- Surgical Specialties Corporation·Product code GAW·May 20, 2016
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
Video Cart Multi-Specialty product labeling is as follows: REF, VP6502, QTY1, Video Cart Multi-Specialty, 120V, Rx ONLY, These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code KQM·February 23, 2010
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
FDA Recall
Terminated
·Surgical Specialties Mexico S DE RL DE CV Corredor Tijuana Rosarito 2000-24702 B Ejido Francisco Villa Tijuana Mexico·Product code OMT·September 24, 2016
CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·November 1, 2010
Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Straight Command Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Custom Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Locking Accolade Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Brand Name: Specialty Woodpecker Adapted Accolade Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·August 19, 2011
25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End
FDA Recall
Terminated
·Surgical Specialties Corp·Product code GEA·November 5, 2002
Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
FDA Recall
Terminated
·Surgical Specialties Corp·Product code HNN·January 7, 2003
Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.
FDA Recall
Terminated
·Surgical Specialties Corp·Product code GAR·September 24, 2005
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
FDA Recall
Terminated
·Surgical Specialties Corp·Product code HNN·August 21, 2003
SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
FDA Recall
Terminated
·Surgical Specialties Corp·Product code DTH·March 30, 2011
Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)
FDA Recall
Terminated
·Surgical Specialties Corp·Product code GAT·August 25, 2003