November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
AVID Medical, Inc. recalls Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
Hazard: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
November 20, 2024Medical DevicesFDA
Medtronic Neuromodulation recalls Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea
Hazard: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
November 20, 2024Medical DevicesFDA
Bard Peripheral Vascular Inc recalls The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur
Hazard: The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Stryker Corporation recalls Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli
Hazard: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
November 20, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038
Hazard: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
November 20, 2024Medical DevicesFDA
Karl Storz Endoscopy recalls Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Hazard: Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
November 20, 2024Medical DevicesFDA
Topcon Medical Systems, Inc. recalls The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and man
Hazard: The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls URINE KIT, SKU DYKM1845; Component No. 503581
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 50
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
November 20, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls UA KIT, SKU DYKM1690A; Component No. 503581
Hazard: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.