ACL TOP (Base), automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
ACL TOP 700, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
Laser Peripherals
Class I - Dangerous
Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.
Class I - Dangerous
Lack of Sterility Assurance
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
ACL TOP CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
Class I - Dangerous
Potential for sample misidentification.
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Intuitive Surgical
Class I - Dangerous
Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
Class I - Dangerous
Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
RGI Medical Manufacturing
Class I - Dangerous
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Class I - Dangerous
STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
Intuitive Surgical
Class I - Dangerous
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Microline Surgical
Class I - Dangerous
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical
Class I - Dangerous
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.