FDA medical device recalls

Olympus Corporation is removing Olympus Thunderbeat 5 mm, 45 cm pistol grip surgical instruments (Model TB-0545PC) from the market due to ongoing reports of adverse events during use. This Class II recall affects approximately 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.

Olympus Corporation is recalling the Thunderbeat 5 mm, 20 cm front-actuated grip surgical instrument due to continued reports of adverse events during use. The recall affects all lots of this model worldwide, including the US and several other countries.

Olympus is removing the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip surgical instrument (Model TB-0535FC) from distribution due to ongoing reports of adverse events during use. The device has been distributed worldwide, including across the US and several other countries.

Olympus is recalling the Thunderbeat 5 mm, 45 cm Front-Actuated Grip surgical instrument (Model TB-0545FC) worldwide due to continued reports of adverse events during use. The company has determined that removal of this device from the market is necessary.

Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments (Model TB-0520FCS) from the market due to ongoing reports of adverse events during use. The company has identified a safety concern affecting all lots of this device.

Olympus is recalling its Thunderbeat 5 mm, 35 cm Front-Actuated Grip Type S surgical instruments (Model TB-0535FCS) due to ongoing reports of adverse events. The recall affects 88,268 units distributed worldwide, including in the United States, Brazil, Canada, Germany, Mexico, and Japan.

Olympus Corporation is removing the Thunderbeat 5 mm, 45 cm Front-Actuated Grip Type S surgical instrument from use worldwide due to ongoing reports of adverse events during use. This affects approximately 9,542 units across the US and several other countries.

Medica Corporation's capillary tubes used with EasyBloodGas and EasyStat devices are giving false potassium results—up to 20% higher than actual levels. This could lead doctors to misinterpret a patient's potassium levels and provide incorrect treatment.

Immunotech's Estrone RIA diagnostic kit may rarely produce falsely high hormone test results in patients. This could potentially lead to unnecessary or incorrect medical decisions. The issue affects only specific lot numbers and occurs very infrequently.

Baxter Healthcare released 5 Spectrum IQ infusion pumps (model 3570009) without completing required safety tests, including tests of the occlusion alarm that alerts users to blockages. The pumps were distributed in Ohio. No injuries have been reported.

Bard Peripheral Vascular is recalling multiple central venous catheter trays and kits because the outer packaging may be damaged, which could compromise the sterile barrier that protects the medical device. The recall affects several Broviac and Hickman catheter products with specific lot numbers manufactured between April 2028 and August 2030.

Medline Industries is recalling 23 models of IV administration and extension sets because the male connectors may leak, crack, or break during use under certain conditions. This could cause delays in treatment, blood loss, infection, air embolism, or patients not receiving the correct medication dose.

CVS Private Label wound care gel (model CVS405406) may have packaging defects that could compromise the sterile barrier protecting the product. This affects specific lot numbers and could allow contamination of the gel used for minor burns, cuts, and abrasions.

Integra LifeSciences has recalled certain lots of MEDIHONEY Calcium Alginate dressing due to potential packaging failures that could compromise the sterile barrier. If the sterile seal is broken, the wound dressing may become contaminated before use. This affects three model numbers distributed worldwide, including to healthcare facilities in the US and internationally.

Integra LifeSciences is recalling specific batches of MediHoney Gel wound dressing because the sterile packaging may fail, potentially allowing contamination. This affects models 31805 and 31815 distributed worldwide. No injuries have been reported.

Wilson-Cook Medical is recalling certain Teslatome Bipolar Sphincterotomes (medical devices used during endoscopic procedures) because some units may contain a manufacturing defect—a void in the material that separates internal channels. This defect can cause electrical current to flow incorrectly during the cutting procedure.

Olympus has recalled the High Flow Insufflation Unit Model UHI-3 due to a software algorithm issue that can cause overpressure events during abdominal cavity insufflation procedures. This medical device is used in laparoscopic surgery to maintain proper pressure and clear the surgical field. No injuries have been reported.

Olympus has recalled its High Flow Insufflation Unit (Model UHI-2) used during abdominal surgery because a software problem may cause the device to create excessive pressure in the abdominal cavity. The issue affects all 744 units distributed nationwide. No injuries have been reported.

Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.

Steris Corporation identified that a limited batch of MNA-6x0 adapter components used in the Barco MNA with HexaVue IP Integration System were manufactured with an incorrect configuration file. This affects 10 units with specific serial numbers distributed across seven states.

Surepulse Medical has recalled the VS Cap Extra Large component used in their VS Newborn Heart Rate Monitor because the labeling includes an incorrect sizing guide. This could lead to improper fit of the cap on the monitor. No injuries have been reported.

The labeling for the Surepulse VS Cap Large, a component of the VS Newborn Heart Rate Monitor, contains an incorrect sizing guide. This labeling error could lead to improper fit of the cap during use. No injuries have been reported.

Surepulse Medical has recalled the VS Cap Medium (part number SP-161-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling contains an incorrect sizing guide. This labeling error could affect proper fit of the cap during use.

The labeling for the Surepulse VS Cap Small component of the VS Newborn Heart Rate Monitor contains an incorrect sizing guide. This affects specific lot numbers distributed in the US and several other countries. No injuries have been reported.

Surepulse Medical has recalled the VS Cap Extra Small (REF: SP-159-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling includes an incorrect sizing guide. This labeling error could lead to improper cap selection for the device.

Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.

Philips Azurion 5 M20 X-ray imaging systems may move their patient table unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could occur under certain conditions and pose a risk during medical procedures.

The table on certain Philips Azurion 5 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects 326 units distributed worldwide, including 10 in the United States. No injuries have been reported.

Philips Azurion 7 M20 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This can occur under certain conditions across all software versions (R1.X, R2.X, R3.X). No injuries have been reported.

Philips medical imaging systems (Azurion 7 M12) may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This affects certain software versions across multiple model numbers. No injuries have been reported.