South Dakota recalls

Medline identified quality issues in specific lots of its DR FERNANDEZ medical procedure kits. The catheter components had surface irregularities, connectors that detached prematurely, and diameter measurements that didn't meet specifications.

Medline found that certain medical procedure kits did not meet quality standards during an internal review. The kits contained catheters with surface irregularities, connectors that detached prematurely, and in some cases outer diameters that did not meet specifications.

Medline identified quality issues in several medical procedure kit models during an internal review. The kits contained catheters with surface irregularities, connectors that could detach prematurely from the catheter funnel, and in some cases catheters with dimensions outside acceptable specifications.

Medline identified quality issues in certain urethroplasty procedure kits during an internal review. The catheters had surface irregularities, connectors that could detach prematurely, and some did not meet size specifications.

Medline identified quality issues in certain lots of its Tonsil Pack Cath medical procedure kits. Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and dimensional specifications not being met in some units.

Medline identified that samples of multiple surgical procedure kits did not meet performance standards. The kits contained catheters with surface irregularities, connectors that detached prematurely, and diameter measurements that fell outside specifications.

Medline identified manufacturing defects in certain batches of 22F Robinson sterile catheter kits. Some catheters had rough surface finishes, connectors that detached prematurely, or outer diameters that didn't meet specifications. About 1,000 units were affected worldwide.

Medline identified quality issues in several medical procedure kits during an internal review. Some catheters had surface irregularities, connectors that detached prematurely, or outer diameters that did not meet specifications. The affected kits include tracheostomy tube inserts, T&A kits, ear packs, and other surgical procedure kits.

Medline identified quality issues in representative samples of its Oral Restoration Medical Procedure Kit (SKU DYNJ86253A). Problems include irregularities in the catheter surface, premature detachment of the catheter connector, and cases where the catheter diameter did not meet specifications.

Medline identified quality issues in certain batches of its Bilateral Micro Vasectomy Reversal Kit (SKU DYNJ68302). Problems include surface irregularities on catheters, premature detachment of catheter connectors, and diameter inconsistencies. No injuries have been reported.

Medline identified that samples of five medical procedure kit models did not meet quality standards. The kits contained catheters with surface irregularities, connectors that detached prematurely, and diameter measurements outside specifications. These defects could affect proper catheter function during medical procedures.

Medline identified that certain batches of medical procedure kits used in open-heart and cardiac surgeries did not meet quality standards. Issues found include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameters. No injuries have been reported.

Medline Industries identified that samples of multiple cardiac and vascular surgery kits did not meet performance standards. The kits contained catheters with surface irregularities, connectors that could detach prematurely, and in some cases, outer diameters that were out of specification.

Medline identified defects in laparoscopy procedure kits (SKU DYNJ37378A) during an internal review. The catheter connector may detach prematurely, the catheter surface finish may be irregular, or the catheter diameter may not meet specifications.

Medline identified that samples of their 16 Fr intermittent latex catheter with pre-connected collection bag did not meet quality standards. The issues include rough spots on the catheter surface, connectors that may detach prematurely from the catheter, and in some cases, the catheter diameter being out of specification.

Medline identified quality issues in its 14 Fr intermittent latex catheter with pre-connected collection bag. Problems include rough spots on the catheter surface, connectors that may detach prematurely, and some catheters that don't meet size specifications.

Medline found that samples of its 15 Fr urethral catheterization trays did not meet quality standards. Problems included rough spots on the catheter surface, connectors that could detach from the catheter funnel, and catheters with incorrect outer diameter in some cases.

Medline Industries recalled its Pre-connected Urethral Catheterization Tray (15 Fr, model DYND10407) after finding that some units did not meet quality standards. Problems included rough catheter surfaces, premature separation of the connector from the funnel, and variations in catheter diameter. No injuries have been reported.

Medline identified that some urethral catheterization trays (15 Fr size, product numbers DYNC1816 and DYND10350) did not meet quality standards. Problems include irregular catheter surface finish, connectors that may detach prematurely from the catheter funnel, and some catheters with incorrect outer diameter.

Medline identified that samples of their red rubber latex urethral catheters did not meet performance standards. Issues included rough surface finishes, connectors that detached prematurely from the catheter funnel, and some catheters with outer diameters outside specification. This recall affects 11 product sizes distributed worldwide.

The Mito Red Light Super Mobile near-infrared therapy device contains a lithium-ion battery that may malfunction and catch fire or burst into flames. The device has been distributed worldwide, including across the United States.

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed infant beds. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners disengaging could cause the canopy soffit to loosen or detach entirely.

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed Carestations. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners may disengage, causing the canopy soffit to loosen or detach.

GE HealthCare identified a potential problem with fasteners that secure the canopy soffit (the cover beneath the control panel) on Giraffe OmniBed infant incubators and warmers. During transport or impact, one or more of these fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners can disengage, causing the soffit to become loose or detach.

ConMed Corporation is recalling certain lots of AirSeal 12mm Access Port and Palm Grip Obturator devices used during laparoscopic surgery. The devices may generate false overpressure alerts that could disrupt surgical procedures.

ConMed has recalled certain lots of its AirSeal 12mm Access Port with Low Profile Obturator (a surgical instrument used in minimally invasive laparoscopic procedures) due to a potential malfunction in the overpressure alert system. The affected devices may fail to properly alert during elevated pressure conditions.

ConMed has recalled certain lots of the AirSeal 12mm Access Port with Palm Grip Obturator (catalog number iAS12-150LPI), a surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use, which could affect the surgeon's ability to maintain proper insufflation during surgery.

ConMed Corporation is recalling certain batches of the AirSeal 5mm Access Port with Low Profile Obturator (catalog number iAS5-100LP), used during laparoscopic surgery to maintain gas pressure in the abdomen. The device may generate overpressure alerts that could affect surgical workflow. No injuries have been reported.

ConMed Corporation has recalled certain lots of the AirSeal 5mm Access Port and Low Profile Obturator (catalog number iAS5-120LP), a disposable surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use. This recall affects approximately 196,751 units distributed nationwide and internationally from June 2024 through January 2026.

ConMed has recalled certain lots of the AirSeal 5mm Access Port with Low Profile Obturator, a surgical instrument used in laparoscopic procedures. The device may generate overpressure alerts that could affect proper operation during surgery.