FDA medical device recalls

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.

ConMed Corporation is recalling certain AirSeal 8mm Access Port and Low Profile Obturator devices (catalog number iAS8-100LP) used in laparoscopic surgery. The devices may generate false overpressure alerts during use. No injuries have been reported.

ConMed Corporation is recalling specific lots of its AirSeal 8mm Access Port with Low Profile Obturator (catalog number iAS8-120LP) used in laparoscopic surgery. The device may generate overpressure alerts that could affect proper operation during procedures. The recall affects approximately 55,694 packs distributed nationwide and internationally.

ConMed Corporation recalled certain AirSeal 12mm Access Ports (catalog number iASB12-100) used in laparoscopic surgery due to a potential for overpressure alerts. The affected devices were manufactured between June 2024 and January 2026, and were distributed nationwide and internationally.

ConMed Corporation is recalling certain AirSeal 12 mm Access Port and Obturator units (catalog iASB12-120) used in laparoscopic surgery because they may fail to generate proper overpressure alerts. This could allow pressure levels to rise unexpectedly during procedures. The affected units were manufactured between June 2024 and January 2026.

ConMed Corporation is recalling certain AirSeal 5mm Smooth Access Ports (Catalog Number iASB5-150) used in laparoscopic surgery. The device may generate overpressure alerts during use, which could affect surgical workflow or require device replacement during a procedure.

Stryker identified that some Triathlon Universal Baseplate Size 3 units (lot UZD9IB) were packaged in boxes labeled as Size 4, while Size 4 units (lot TYX7OB) were packaged in boxes labeled as Size 3. This labeling mix-up could result in using the wrong implant size during surgery.

Accriva Diagnostics' directCHECK ACT-LR whole blood quality control product (level 2, lot A6DLA001) has incorrect performance range information on its label. This labeling error could lead to misinterpretation of test results if the correct reference range is not known.

AMD Medicom Inc. is recalling Ritmed Neurological Sponges (0.75x0.75in, Sterile, REF: 85995C) used during brain surgery because some units may not meet safety standards for endotoxin—a bacterial byproduct that can cause harmful reactions in the cerebrospinal fluid. Elevated endotoxin levels could lead to fever, inflammation, low blood pressure, nausea, or neurological complications.

Ritmed Neurological Sponges used during brain surgery may contain elevated endotoxin levels. Endotoxins are bacterial contaminants that can trigger inflammation, fever, or temporary blood pressure drops when sponges contact cerebrospinal fluid during surgery.

Abiomed's Impella CP Set with SmartAssist may experience low purge pressure issues that trigger repeated alarms. In some cases, this malfunction can interrupt or stop the device's mechanical heart support function.

Smith & Nephew identified a manufacturing error in certain TRIGEN Proximal Straight Humeral Nails (8/7 X 16, Ref: 71760816) in which the distal holes are missing. If implanted without detection, the affected nail could require revision surgery. Five units were distributed internationally.

Medtronic has identified a firmware anomaly in the O-arm O2 Imaging System detector panel that can cause image artifacts during surgical imaging. The issue affects specific serial numbers of the O-arm O2 model BI70002000. No injuries have been reported.