Is My Product Recalled? Free U.S. Recall Search

Showing 501–520 of 1781 results
Sort:
Newest first Oldest first
Integra LifeSciences Corp.: CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter S...
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
FDAMay 7, 2024Nationwide• Integra LifeSciences Corp.
Integra LifeSciences Corp.: CODMAN BACTISEAL EVD Catheter Set - Indicated for gainin...
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
FDAMay 7, 2024Nationwide• Integra LifeSciences Corp.

Foam Pattern Rollers (Creativity Street) – lead contamination (2024)
This recall involves Creativity Street Foam Pattern Rollers with model PAC5170, which are intended for children to use when painting. Lot codes "02142080423" and "02142230523" are included in the recall and are printed on the back of the packaging. The foam pattern rollers come in four assorted patterns, with yellow, green, blue, and red handles.
CPSCMay 2, 2024Nationwide

Getinge Usa Sales Inc: Vaporizer Sevoflurane Maquet Filling, Product code/REF nu...
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
FDAMay 1, 2024CA, CO, IN +4 more• Getinge Usa Sales Inc

Outset Medical, Inc.: TabloCart with Prefiltration Drawer PN-0006813, with powe...
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
FDAApr 30, 2024Nationwide• Outset Medical, Inc.

Covidien, LLC: EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx...
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
FDAApr 25, 2024Nationwide• Covidien, LLC

Philips North America Llc: Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Res...
Fire/Burn Risk
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
FDAApr 22, 2024Nationwide• Philips North America Llc

Philips North America Llc: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Reson...
Fire/Burn Risk
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
FDAApr 22, 2024Nationwide• Philips North America Llc

Boston Scientific Neuromodulation Corporation: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pu...
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
FDAApr 18, 2024Nationwide• Boston Scientific Neuromodulation Corporation

Beckman Coulter, Inc.: Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF...
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
FDAApr 18, 2024FL, GA, IN +6 more• Beckman Coulter, Inc.

NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark: Intelli-C: Right side suspended Tabletop, REF: 03400000; ...
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
FDAApr 17, 2024Nationwide• NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel: MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ...
There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.
FDAApr 15, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom: HeartSine samaritan PAD (Public Access Defibrillator), Ty...
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
FDAApr 8, 2024Nationwide• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

Philips Respironics, Inc.: OmniLab Advanced + Ventilator Product Numbers 1111122 1...
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
FDAApr 1, 2024Nationwide• Philips Respironics, Inc.

Philips North America Llc: The Oncology Essentials Package of the Spectral CT imagin...
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
FDAMar 29, 2024Nationwide• Philips North America Llc

Philips Respironics, Inc.: BiPAP V30 Auto Ventilator, Part Number 1111178
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (...
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OU...
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

EBI, LLC: 20" Lead Wires, Replacement Part Number: 1067724-2
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
FDAMar 22, 2024Nationwide• EBI, LLC