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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Recall
Terminated ·Radiometer America Inc·Product code JJE·May 25, 2018

CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 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.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 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.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

EC20CS EPIDURAL CATHETER, Material Number 333532 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.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 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.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV

FDA Recall
Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 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.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

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

FDA Recall
Terminated ·Dannoritzer Medizintechnik GmbH & Co. KG Sattlerstr. 25 Tuttlingen Germany·Product code GEI·August 6, 2018

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWC·September 4, 2018

Capnostream20 M ADULT ICU (CPM), CS08654RA

FDA Recall
Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018