FDA Closes Fresenius Kabi Recall of 4,643 Tyenne Vials
The FDA has terminated its Class I enforcement action over glass particles in Tyenne (tocilizumab-aazg) Injection, meaning the agency considers the recall carried out.
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The FDA has terminated its Class I enforcement action over glass particles in Tyenne (tocilizumab-aazg) Injection, meaning the agency considers the recall carried out.
The FDA has classified the recall as Class II, indicating the product may cause temporary or medically reversible harm.
The FDA has terminated its enforcement action on 3,468 Medline neurological convenience kits recalled for potential out-of-specification endotoxin levels in the neurosponges they contain.
The FDA has classified the recall of 14 Medline convenience kit lines as Class II, meaning the product may cause temporary or medically reversible harm.
FDA classifies the action as Class II, saying the chance of serious harm is remote.
FDA lists action as Class II recall; kits contain a component recalled by the manufacturer.
The agency has closed the Class II recall of certain heated wire breathing circuits distributed by Medline Industries, LP.
The agency has closed the Class II recall of Medline Hudson RCI heated wire breathing circuits, citing completion of the corrective action.
The agency considers the recall carried out; consumers are urged to check the listed lot numbers.
FDA classifies recall of Medline Micro-Kill Bleach Germicidal Wipes as Class II due to potential loss of bleach concentration before shelf life ends.
The FDA has closed the Class I recall of certain Baxter solution administration sets, meaning the agency considers the recall carried out.
FDA classifies the action as Class II, citing a potential drop in bleach concentration below specification before the labeled shelf life ends.
An FDA enforcement report classifies the ongoing action as Class II, the agency's middle category.
Bear Stewart Co recalled 313 cases of Brown Butter Chocolate Chunk Ready to Bake Cookie Dough distributed through Target stores in four states, according to the FDA enforcement record.
An FDA enforcement report lists a Class II, nationwide recall of one lot of 1% lidocaine HCl injection initiated on July 16, 2026.
The agency's enforcement record cites the potential for brush heads to break; the nationwide action remains ongoing.
An FDA enforcement report lists an ongoing recall by Medline Industries, LP of convenience kits containing recalled Bard Silastic Foley catheters, distributed in five states.
An FDA enforcement report filed under recall number Z-2782-2026 lists 980 Medline convenience kits containing Bard Silastic Foley catheters, with the recall status ongoing.
An FDA enforcement report says the brush heads have the potential to break; the action is listed as ongoing.
The agency's enforcement report for recall Z-2747-2026 traces the action to a voluntary recall of a bupivacaine injection supplied within the kits.
The enforcement record cites an increased amount of raw material on the catheter surface; the action is listed as ongoing.
An FDA enforcement report lists nine kit types containing BD PurPrep 26 mL as Class II, with the recall still ongoing.
An FDA enforcement report lists the Class II action as initiated June 8, 2026 and still ongoing.
An FDA enforcement report dated July 29, 2026 lists the nationwide Class II recall of a single lot of the 0.5% ropivacaine hydrochloride injection as ongoing.
An FDA enforcement report lists the Class II recall as ongoing, covering kits distributed nationwide with catheters recalled by their manufacturer over raw material on the catheter surface.
An FDA enforcement report dated July 29, 2026 lists a nationwide Class II recall by Fresenius Kabi USA, LLC of one lot of lidocaine HCl injection.
An FDA enforcement report lists the recall as Class II and ongoing, covering shoulder and major orthopedic packs distributed in ten states.
An FDA enforcement report classifies the nationwide Class II recall of a single lot of 2% lidocaine injection as ongoing.
An FDA enforcement report dated July 29, 2026 lists the nationwide Class II recall as ongoing.
Enforcement report Z-2765-2026 says the knee and hip procedure kits contain recalled ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP.
An FDA enforcement report says the pump may in a specific scenario deliver up to twice the programmed volume to be infused.