FDA Class II Recall Issued for IMRIS ORT200 Operating Room Tables
The FDA has announced a Class II recall of certain IMRIS ORT200 operating room tables due to a mechanical failure risk that could cause unintended movement during procedures.
Recalls & Safety Alerts in Minnesota
Every recalls & safety alerts report published for Minnesota, newest first.
FDA Reports Ongoing Recall of Medtronic Arterial Cannulas
An open Class II recall covers 1,424 arterial cannula units distributed worldwide due to potential pinhole leaks.
FDA Closes Recall of Medtronic Arterial Cannulas
The agency has closed the recall of certain Medtronic arterial cannulas, considering it carried out.
FDA Enforcement Record Classifies Recall of Medtronic Arterial Cannulas
The ongoing Class II recall covers 3,621 units of arterial return cannulas due to potential pinhole leaks.
Boston Scientific Recalls 74,760 FARADRIVE Steerable Sheaths Over Valve Damage Risk
An FDA enforcement report lists the Class II recall, initiated June 11, 2026, as ongoing, citing hemostatic valve damage linked to dilator insertion during device preparation.
FDA Records Ongoing Class II Recall of LEADER Carbamide Peroxide 6.5% Ear Drops
An FDA enforcement report lists 5,471 units of the 0.5 fl oz product recalled nationwide as subpotent, with the action initiated June 25, 2026.
Boston Scientific Replacing Six FARASTAR Ablation Generators in Europe Over Catheter Incompatibility
An FDA enforcement report lists a Class II action covering six pulsed field ablation generators distributed in five European countries.
Boston Scientific Recalls 11 FARASTAR PFA Generators Over Labeling Discrepancy
An FDA enforcement report lists the Class II action, initiated June 11, 2026, as ongoing after devices shipped with instructions omitting FARAPOINT PFA catheter information.
FDA Lists Class II Recall of 1,201 Bottles of CAREone Carbamide Peroxide 6.5%
An ongoing nationwide recall of a single lot "Lot:1505141", "exp 2027-04." cites a sub-potent drug with low pH and a significantly reduced assay, according to the agency's enforcement record.
FDA Records Nationwide Class II Recall of 29,474 Units of Clinere Carbamide Peroxide
The agency's enforcement report cites a sub-potent drug with low pH and a significantly reduced assay; the recall is listed as ongoing.
Boston Scientific Recalls One FARASTAR Ablation Generator Over Missing Catheter Instructions
An FDA enforcement report says instructions supplied with the device omitted FARAPOINT PFA catheter information; the Class II action is listed as ongoing.
FDA Records Ongoing Class II Recall of FAMILY Wellness Earwax Removal Kits
An FDA enforcement report lists 11,977 units of a carbamide peroxide 6.5% kit recalled nationwide as subpotent, with the action still ongoing.
Boston Scientific Recalls 18 FARASTAR Ablation Generators in Europe Over Missing Catheter Instructions
An FDA enforcement report classifies the ongoing Class II action, which covers units distributed in nine European countries, as a labeling discrepancy.
FDA Records Nationwide Class II Recall of QC Quality Choice Carbamide Peroxide Drops
An FDA enforcement report lists 15,843 units of the 6.5% ear drops recalled by Bell Pharmaceuticals, Inc for reduced potency; the action is ongoing.