68 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD
FDA Enforcement
Class II
·Ongoing·YAMAHA MOTOR CORPORATION·May 29, 2024
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
FDA Enforcement
Class II
·Ongoing·Covidien·July 30, 2025
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·June 12, 2019
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Enforcement
Class II
·Ongoing·Brasseler USA I Lp·February 14, 2024
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
FDA Enforcement
Class II
·Ongoing·Medtronic Inc·August 10, 2022
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 3, 2024
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 3, 2024
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 3, 2024
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·November 23, 2022
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 17, 2024
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 3, 2024
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 14, 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 Enforcement
Class II
·Ongoing·Covidien Llc·June 10, 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 Enforcement
Class II
·Ongoing·Covidien Llc·June 10, 2020
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 3, 2024
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 27, 2024