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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Bronchovideoscope BF-Q180-AC

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

Dannoritzer Medizintechnik GmbH & Co. KG

Class I - Dangerous

The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

Aug 6, 2018 Surgical Instruments Nationwide View Details →

CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Bronchofiberscope BF-XP40

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

Bronchofiberscope BF-XP60

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

Bronchovideoscope BF-160

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Bronchofiberscope BF-XT40

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →

EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169, 530171, 530175, 530177, 530179, 530180, 551028, 551266, 551342, 551344, 551394, 551411, 551437, 551474, 551554, 551572, 551624, 551630, 551671, 551672, 551714, 551731, 551732, 551749, 551769, 551771, 551773, 551791, 551810, 551816, 551849, 551859, 551875, 551879, 551889, 551920, 551922, 551938, 551942, 551951, 551971, 551994, 551997, 551998, 552006, 552011, 552020, 552021, 552030, 552031, 552038, 552041, 552047, 552048, 552051, 552076, 552077, 552079, 552083, 552089, 552099, 552100, 552101, 552112, 552113, 552116, 552117, 552119, 552121, 552122, 552123, 552125, 552126, 552133, 552135, 552136, 552147, 552149, 555030, 555040, 555051, 555061, 555063, 555067, 555070, 555076, 555079, 555083, 555091, 555098, 555100, 555110, 555170, 555172, 555175, 555202, 555204, 555215, 555217, 555259, 555271, 555277, 555290, 555296, 555299, 555325, 555340, 555357, 555374, 555421, 555422, 555438, 555449, 555450, 555482, 555483, 555484, 555498, 555525, 555551, 555569, 555578, 555579, 555601, 555647, 555660, 555704, 555706, 555757, 555779, 555854, 555857, 555884, 555904, 555931, 555951, 555987, 570180, 570205, 570222, 570234, 570245, 570246, 570269, 570285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

Ortho Clinical Diagnostics

Class I - Dangerous

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

Jul 12, 2018 Diagnostic Equipment Nationwide View Details →