Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
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
- 2024-11-20FDA-DeviceAVID Medical, Inc.Class IIHalyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
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
- 2024-11-20FDA-DeviceMedtronic NeuromodulationClass IIMedtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- 2024-11-20FDA-DeviceBard Peripheral Vascular IncClass IIThe EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with tou
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.
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703
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
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-001
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
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-000
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
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-001
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
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-002
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
- 2024-11-20FDA-DeviceStryker CorporationClass IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-000
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
- 2024-11-20FDA-DeviceOlympus Corporation of the AmericasClass IIBrand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices
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.
- 2024-11-20FDA-DeviceKarl Storz EndoscopyClass IIIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
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.
- 2024-11-20FDA-DeviceTopcon Medical Systems, Inc.Class IIThe IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of pos
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
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIURINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
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.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIURINE KIT, SKU DYKM1845; Component No. 503581
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.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIURINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
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.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIURINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
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.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIURINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
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.
- 2024-11-20FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIUA KIT, SKU DYKM1690A; Component No. 503581
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.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief