FDA medical device recalls

The HeartMate 11 Volt Lithium Ion Backup Battery, a critical component of the HeartMate 3 System Controller, can fail to provide emergency power when needed. The backup battery is designed to supply at least 15 minutes of emergency power if the main power source fails. Battery failures could prevent the system controller from operating during power loss.

The HeartMate 3 System Controller, which powers and monitors left ventricular assist devices (LVADs), may experience failures in its 11-volt backup battery. This backup battery is critical for emergency power when other power sources are unavailable.

Merit Medical Systems' Splashwire Hydrophilic Guide Wire — used by doctors in vascular procedures — has been recalled because some product pouches were not sealed properly. Unsealed pouches can allow contamination or damage to the sterile device before use.

Inspire Medical Systems' Model 4063 stimulation leads are labeled with expiration dates that extend beyond their actual three-year shelf life. If a lead is used after its true expiration date, the material may degrade and could require unplanned revision surgery. A small number of units (10 total) have been affected worldwide.

Inspire Medical Systems' Respiratory Sensing Lead (Model 4340) was labeled with expiration dates that extend beyond the validated three-year shelf life. If the device is used after its actual expiration date, the material may degrade and could require unplanned revision surgery.

BD Connecta BD Luer-Lok 360 stopcocks used to administer IV fluids and medications may have a connection problem at Port C. When a plastic luer-lok syringe is attached, the connection may over-thread or continue spinning instead of tightening securely, making it feel unstable.

A firmware bug in the iLet Bionic Pancreas can cause the lock screen to fail to unlock when users slide the unlock slider. When this happens, users become stuck on the lock screen and cannot change insulin cartridges or enter meal information. The pump will continue delivering insulin until the cartridge empties and the battery drains, which may lead to high blood sugar.

Staar Surgical's ICL Calculation Software Version 8.00 contains a coding error that can produce incorrect implantation orientation diagrams for toric intraocular lenses. The error occurs when multiple toric lens calculations are generated for the same eye between April 13–16, 2026. An incorrect diagram could lead to improper lens alignment during surgery.

Medline identified that certain surgical procedure kits containing catheters did not meet quality standards. Some kits had catheters with surface irregularities, connectors that could detach prematurely, or catheters that were the wrong size.

Medline identified that samples of several medical procedure kits did not meet quality specifications. Issues included rough catheter surfaces, connectors that detached prematurely, and catheters with incorrect outer diameters. These kits are used in eye and throat surgical procedures.

Medline identified that samples of several medical procedure kits did not meet performance standards. Issues included irregular catheter surface finish, premature connector detachment, and catheters with incorrect outer diameter.

Medline Industries identified that certain batches of medical procedure kits used in gynecological surgeries did not meet quality standards. The kits contained catheters with surface irregularities, connectors that could detach prematurely, and sizing issues that could affect proper function during procedures.

Medline identified that certain D and C Pack and catheter kits did not meet quality specifications. Issues found include surface irregularities on catheters, connectors that detached prematurely from the catheter funnel, and catheters with incorrect outer diameter. The affected kits were distributed worldwide.

Medline identified that samples of its medical procedure kits did not meet quality standards. The catheter components had surface irregularities, connectors that detached prematurely, and in some cases incorrect outer diameters.

Medline identified quality issues in representative samples of its Pelvic Lap Pack medical procedure kit (SKU DYNJ53820B). Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and instances where the catheter diameter fell outside specification. A total of 20 units were affected.

Medline found that samples of several obstetric and gynecological procedure kits did not meet quality standards. The issues include surface irregularities on catheters, connectors that detached prematurely from catheter funnels, and catheters with diameters outside acceptable specifications.

Medline identified that certain batches of carotid neuro and VP shunt procedure kits did not meet performance specifications. Issues include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameter measurements.

Medline identified quality issues in certain Nursing Kits (SKU EDUC1044) during an internal review. The catheter components did not meet specifications—including surface irregularities, connectors that detached prematurely, and some catheters that were the wrong diameter. About 730 kits were affected.

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.