The manufacturer has not yet reported a final root cause; the investigation is still open. The FDA lists 1,213 recalls with this root cause since 2025, 200 of them Class I (most serious). Most recent report: Aug 19, 2026.
Due to an increase rate of balloon pinhole defects.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.…
Due to increase in false negative results
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.