B. Braun 21GA WINGED INFUSION, SINGLE PK recall — FDA Z-1482-2026
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and…
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0:…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for…
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.
There is the potential for the length of the trocar shaft to be too long.
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 the potential for…
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or…
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Potential for rubber fragment detachment during use.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Potential for rubber fragment detachment during use.
Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.
Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
Products contain undeclared milk and soy.
Potential contamination with patulin.
Products contain undeclared milk and soy.
CGMP Deviations
Presence of Particulate Matter: Due to production issues
Browse recent months with enough recall history for useful comparison.