Medicine, medical device and cosmetics recalls in United States
Recalls of medicines, medical devices, supplements, cosmetics and personal care products published in United States, newest first.
1,518 recalls, newest first · Checked 19 minutes ago
Physio-Control, Inc. recalls PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers…
Due to pediatric defibrillator electrode delaminationExactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog… and 1 more products
Impactor handle may be missing cross-pinMedline Industries, LP recalls Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient…Raz Design Inc recalls Raz-AT
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.International Life Sciences recalls Artelon FlexBand Dynamic Matrix Ref: 31057 and 2 more products
Augmentation devices failed bacterial endotoxin testing.Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucose… and 3 more products
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.Beckman Coulter Mishima K.K. recalls DxC 700 AU and 1 more products
A delay in results may occur.Instrumentation Laboratory recalls GEM Premier 5000 PAK and 19 more products
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not…Penner Patient Care, Inc. recalls Penner Pacific Bathing Spa and 9 more products
The device does not bear a unique device identifier.Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau and 12 more products
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor…
Behind-the-ear sound processer packaging label is different then included product.Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output.Vascutek, Ltd. recalls Gelsoft Plus
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S…
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas.Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin
Falsely depressed UAlb patient results may occur.Datascope Corp. recalls CS100 IABP. Software Version CS100 IABP Q.01. and 1 more products
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with…Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays.Esaote S.p.a. recalls Esaote Endocavity ultrasonic probe
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.Aesculap Inc recalls Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog…
There is the potential for the length of the trocar shaft to be too long.Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is…B Braun Medical Inc recalls Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog… and 2 more products
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.A little guidance
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