Medical device recalls

Zimmer has recalled a plastic reamer guide used in shoulder surgery because the plastic can catch and break during the reaming procedure. Five complaints have been received describing this issue. No injuries have been reported.

PFM Medical's Multi-Snare Set catheters (5 mm and 10 mm models) failed to meet biocompatibility safety standards. If used, the device material could cause localized inflammation and tissue irritation when in contact with blood vessels.

Ventec Life Systems' VOCSN+Pro respiratory ventilator may have a damaged backup battery that powers the alarm system. If primary power is lost and the backup battery is depleted or absent, the backup alarm may not sound to alert caregivers of the power loss.

TMJ Solutions Inc. has recalled one custom temporomandibular joint implant (model CHG020) that may contain incorrect patient-specific components. The mismatch caused a poor fit, resulting in a right-sided open bite for the affected patient.

Certain Philips Avalon FM 30 fetal monitors have an incorrect speaker connector assembly that can allow device cables to be pulled out of the housing. This defect may cause the speaker to stop working intermittently or permanently, which could affect audio output during monitoring.

Certain Philips Avalon FM20 Fetal Monitors have a speaker connector that was assembled incorrectly. This defect can cause cables to pull out of the device housing, which may result in loss of speaker output—either intermittently or permanently. This affects audio alerts that are critical to clinical monitoring.

Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

Medline Convenience Kits containing anesthetic medications (Lidocaine and Bupivacaine injections) were recalled due to quality issues found during an FDA inspection of the supplier. The affected kits are used in medical procedures including central line placement and open heart surgery.

Medline Convenience Kits containing Arrow Kits and Sets with Lidocaine and Bupivacaine anesthetic injections were recalled due to quality issues found during an FDA inspection of the supplier. The kits are used for central and arterial line procedures in medical settings. A total of 233 units were distributed nationwide.

Medline Convenience Kits used in cardiac surgery contain anesthetic medications (Lidocaine and Bupivacaine) that were recalled by their supplier due to quality concerns found during an FDA inspection. About 6,775 affected kits have been distributed to hospitals and surgical centers.

Medline Convenience Kits used in cardiovascular anesthesia room setups contain anesthesia injectables (Lidocaine and Bupivacaine) that were recalled due to quality problems found during an FDA inspection of the supplier. The affected kits are used in hospital operating rooms.

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.