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Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Recommendations for Precice devices due to ongoing biocompatibility evaluation.
Quidel is recalling the Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with high virus amounts
Angiographic Guidewire Component is a guidewire to help place catheters into the vasculature.
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
Santo Domingo, Dominican Republic - Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion
Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4 mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed ins
The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.
The recall is due to issues with PE-PUR foam, used to reduce sound and vibration, breaking down and potentially entering the device?s air pathway.
Medical convenience kits group devices together for medical providers. Kits contain ChloraPrep 3mL, which is under recall for fungal contamination risk
Surgical procedure packs group devices together for medical providers. Packs contain Hospira Pfizer 1% lidocaine which may be mislabeled as bupivacaine.
Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes deliver U-100 insulin. Skewed markings on the syringe barrel may lead to insulin overdose or underdose.
Failure to correctly follow manufacturer instructions for reprocessing and device maintenance can potentially result in infection transmission.
Oklahoma City, Oklahoma, Prairie Wolf Spirits, Inc. is voluntarily recalling all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles to the consumer level. The recall does not affect any other hand sanitizer product
Sanit Technologies LLC d/b/a Durisan, is providing an additional 5 label illustrations and product sizes for customers that might not have been able to clearly identify containers of Non-Alcohol Hand Sanitizer products that were added to the voluntary recall initiated on March 24, 2021, and expanded
Smiths Medical has become aware of specific models and lots of Jelco? Hypodermic Needle-Pro? Fixed Needle Insulin Syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified.
Bezel posts on the Alaris Infusion Pump Module 8100 are critical to pump function. Infusion Pump Repair bezel posts may crack or separate.
Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address ide
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
Innova SARS-CoV-2 Antigen Rapid Qualitative Test performance characteristics have not been adequately established, presenting a risk of false results.
The FDA has significant concerns that performance of the test has not been adequately established, presenting a risk to health.
Listing of the 2021 Biologics Recalls
Aziyo Biologics, Inc., (?Aziyo?) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (?FiberCel?) and is voluntarily recalling one Lot of the FiberCel product, Donor Lot Number: NMDS210011.
Medtronic has stopped the sale and distribution of HVAD because the internal pump may delay or fail to restart.
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