All Recalls

95,114 total recalls in our database

OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

GE OEC Medical Systems

🏥 Medical Devices Class I - Dangerous

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

Nov 21, 2024 Diagnostic Equipment Nationwide View Details →

Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Kirwan Surgical Products

🏥 Medical Devices Class I - Dangerous

Potential for the outer stainless-steel tube to break or detach.

Nov 14, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

Draeger Medical

🏥 Medical Devices Class I - Dangerous

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Oct 15, 2024 Other Medical Devices View Details →

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Kirwan Surgical Products

🏥 Medical Devices Class I - Dangerous

Potential for the outer stainless-steel tube to break or detach.

Nov 14, 2024 Diagnostic Equipment Nationwide View Details →

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

Augustine Temperature Management

🏥 Medical Devices Class I - Dangerous

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Dec 4, 2024 Surgical Instruments View Details →

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

CooperSurgical

🏥 Medical Devices Class I - Dangerous

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Nov 15, 2024 Diagnostic Equipment Nationwide View Details →

Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.

Medtronic Neurosurgery

🏥 Medical Devices Class I - Dangerous

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Nov 1, 2024 Diagnostic Equipment Nationwide View Details →

Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

CooperSurgical

🏥 Medical Devices Class I - Dangerous

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Nov 15, 2024 Diagnostic Equipment Nationwide View Details →

Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

Spectranetics

🏥 Medical Devices Class I - Dangerous

Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

Nov 25, 2024 Surgical Instruments Nationwide View Details →

Charmast power banks, model W1056

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.

Dec 19, 2024 Electronics Nationwide View Details →

SKIL 40V 5.0 Ah Lithium-Ion Batteries

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The lithium-ion batteries can overheat, posing fire and burn hazards.

Dec 19, 2024 Electronics Nationwide View Details →

Elongdi Magnetic Building Sticks Sets

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The recalled magnetic building sticks set violates the mandatory federal regulation for magnet toys posing an ingestion hazard. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

Dec 19, 2024 Other Consumer Products Nationwide View Details →