All Recalls | RecallPedia

Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical

🏥 Medical Devices Class I - Dangerous

B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Exactech

🏥 Medical Devices Class I - Dangerous

Vix Bit may fracture during use.

Jul 11, 2017 Surgical Instruments View Details →

BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

Cut resistant surgical glove liners lack sterility assurance.

Sep 11, 2017 Surgical Instruments Nationwide View Details →

Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring

Cook

🏥 Medical Devices Class I - Dangerous

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Jul 31, 2017 Diagnostic Equipment Nationwide View Details →

Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

Cincinnati Sub-Zero Products

🏥 Medical Devices Class I - Dangerous

Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

Nov 27, 2017 Other Medical Devices Nationwide View Details →

Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

Medtronic Neurosurgery

🏥 Medical Devices Class I - Dangerous

Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

Dec 20, 2017 Other Medical Devices View Details →

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

ConforMIS

🏥 Medical Devices Class I - Dangerous

Implant kit mislabeled

Jul 24, 2017 Implants & Prosthetics View Details →

Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

B. Braun Medical

🏥 Medical Devices Class I - Dangerous

B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.

Jun 21, 2017 Surgical Instruments Nationwide View Details →

Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.

Smiths Medical ASD

🏥 Medical Devices Class I - Dangerous

Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.

Jul 15, 2016 Infusion Pumps View Details →

JS Series SterilContainer S2 System

Aesculap Implant Systems

🏥 Medical Devices Class I - Dangerous

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

Sep 8, 2017 Other Medical Devices View Details →

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

GE Medical Systems China Co.

🏥 Medical Devices Class I - Dangerous

Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

Oct 11, 2017 Other Medical Devices Nationwide View Details →

Bleeding drip taper candles

Proud Wealth International LTD, of China

🏠 Consumer Products Class I - Dangerous

The candles' high flame can ignite the surface of the wax, posing a fire hazard.

Feb 21, 2018 Other Consumer Products Nationwide View Details →

Outdoor Gas Fire Pit Table Patio Heaters

Zhejiang Yayi Metal Technology Co., Ltd.

🏠 Consumer Products Class I - Dangerous

The bowl base of the fire pits lacks a heat shield to protect consumers from burns while turning off the propane tank after use, posing a burn hazard.

Feb 21, 2018 Furniture Nationwide View Details →