Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, produ… — Emano Metrics, Inc. · Class II · Ongoing · 685
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator… — Boston Scientific Corporation · Class II · Ongoing · 193,000 units
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. — SEASPINE ORTHOPEDICS CORPORATION · Class II · Ongoing · 796 units
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo d… — PIE Medical Imaging B.V. · Class II · Ongoing · 165
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. — Medline Industries, LP · Class II · Ongoing · 574 kits
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator… — Boston Scientific Corporation · Class II · Ongoing · 400 units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator… — Boston Scientific Corporation · Class II · Ongoing · 508,151 units
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose In… — Medline Industries, LP · Class I · Ongoing · 2301 kits
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. — Olympus Corporation of the Americas · Class II · Ongoing · 10 units
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. — Modern Warrior Life, LLC · Class I · Ongoing · Unknown
A standard chemotherapy drug loaded in nanoparticles has been able to penetrate the blood-brain barrier when administered shortly after resection of the tumor, new research has suggested.