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 0 minutes ago
United StatesICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump and 1 more products
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the…Papablic Inc recalls Papablic Replacement Brush Heads. Model Number: Papablic18B and 1 more products
Potential for brush heads to break.Abiomed, Inc. recalls ABIOMED Impella RP Flex with SmartAssist Set and 12 more products
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.Boston Scientific Corporation recalls Rapid Refill Continuous Injection System
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor.Orthofix U.S. LLC recalls Orthofix MINIRAIL and 3 more products
Unilateral external fixation devices may be incorrectly labeled.Padagis US LLC recalls Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.CareFusion 213, LLC recalls BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicatorBell Pharmaceuticals, Inc recalls CVS Health and 10 more products
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Chiesi USA, Inc. recalls CLEVIPREX
Lack of Assurance of SterilityIntegra LifeSciences Corp. (NeuroSciences) recalls OmniTract Surgical Retractor System
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes.Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS and 1 more products
Due to packaging discrepancy with incorrect product size mixed up.Boston Scientific Neuromodulation Corporation recalls Intracept Access Instruments
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached…Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.Think Surgical, Inc. recalls TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking…
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.Fresenius Medical Care Holdings, Inc. recalls 5008X Blood Tubing Set
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.Elekta, Inc. recalls Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote… and 2 more products
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated…Medline Industries, LP recalls Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF and 2 more products
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr.CMR Surgical Limited recalls Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US…
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump
A software anomaly can occur when the pump is paired with the Instinct sensor.Klowen Braces recalls KL Owen Custom Orthodontic Solution
A product error defect may cause incorrect bracket placement.Wallac Oy recalls GSP Neonatal GALT Kit. Product Codes: 3303-001U
Reduction in the on-board stability of the GSP GALT assay.A little guidance
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