Medical device recalls

Medtronic found a manufacturing error in 2 units of the Octopus Nuvo Tissue Stabilizer where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite of the correct design. This could affect how the device functions during use.

Agiliti Health's Adapt Pump (used in Adapt Air and Adapt Convertible mattresses) has a software issue that prevents the temperature control (Microclimate Management) function from restarting after the Autofirm button is used for 10 minutes during initial setup. This only happens if you let the timer run out without manually stopping it, and it only affects temperature management—not the mattress's air support.

Medline dialysis dressing change convenience kits (SKU DYNDC3167) may contain defective Tego Connectors with silicone seal problems. The seals can dome or tear, which may block fluid flow, cause therapy delays, leak fluids, or allow air or contamination into the bloodstream.

Medline Industries is recalling several dialysis and pheresis dressing change kits because the silicone seals on included Tego Connectors may be damaged, domed, or torn. A damaged seal can prevent blood withdrawal or injection, cause fluid leakage, delay treatment, or allow air or contaminants into the bloodstream.

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Medline dialysis kits containing Tego Connectors may have defective silicone seals that can dome or tear. This can block the fluid path, prevent blood withdrawal, cause fluid leaks, interrupt treatment, or allow air and contaminants into the body.

Medline dialysis on/off kits may contain Tego Connectors with defective silicone seals that can dome or tear. This can block the fluid path, prevent blood product injection or withdrawal, cause fluid leakage, delay treatment, or allow air or contaminants into the body.

Medline Industries is recalling two dialysis insertion kits that contain Tego Connectors with defective silicone seals. The seals may dome or tear, which can block fluid flow, cause therapy delays, allow leaks, or introduce air or contamination into the body.

Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S, and P2HC because they were sold without FDA 510(k) clearance, which is required before medical devices can be marketed in the U.S. The company distributed approximately 11,202 units nationwide. No injuries have been reported.

Edermy LLC's PIE Trolley System Model 2005 was distributed without required FDA 510(k) clearance, which means the device was not reviewed or approved for safety and effectiveness. The FDA has issued a recall affecting 27 units distributed across multiple states.

Encore Medical's RSP Standard Humeral Socket Insert (36mm, HXe-plus model) was distributed with incorrect labeling. About 20 implants from a single lot were affected across multiple states. No injuries have been reported so far.

Encore Medical's EMPOWR 3D Knee implants (model 341-16-707, lot 151T1055A) were distributed with incorrect labeling that could affect proper surgical placement or identification. Fourteen implants were affected across multiple states. No injuries have been reported.

Encore Medical's RSP humeral socket insert (model 509-00-432, lot 385P1263) has incorrect labeling that could cause confusion during surgical implantation. This affects 20 implants distributed across multiple U.S. states. No injuries have been reported.

The ceramic tip on Olympus Resection Sheath Model A2666T can break during use. This device is used in urological procedures. The FDA has determined this poses a risk to patients.

The ceramic tip on Olympus Inner Sheath Model A2642, used in urological endoscopic procedures, can break during use. The FDA has received complaints of this breakage occurring.

Olympus has recalled the Inner Sheath Model A2641, a medical device used in urological procedures. The ceramic tip of the resection sheath can break during use, which may affect the safety and effectiveness of the procedure.

Olympus Corporation is recalling its 10 Fr. Model A37004A endoscopic sheath used in urological procedures because the ceramic tip can break during use. The company has received complaints about this defect. No injuries have been reported.

Olympus has recalled the Inner Sheath 21 Fr. Model No. A2660T, a medical device used in urological procedures. The ceramic tip on the resection sheath can break during use, which could affect the safety and effectiveness of the procedure.

Olympus has recalled its Model A2666 resection sheath, a medical device used in urologic procedures, because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting all lots of this device.

Olympus has recalled its Inner Sheath, Long (Model WA22017T) used in urological and gynecological procedures because the ceramic tip of the resection sheath can break during use. The company received multiple complaints about this defect. About 1,141 units are affected nationwide.

Olympus has recalled its Inner Sheath Long (Model WA22017A), a medical device used in urological and gynecological procedures. The ceramic tip on the resection sheath can break during use. The FDA has classified this as a Class II recall affecting 437 units distributed nationwide.

The ceramic tip on Olympus Inner Sheath Model A4741, used in gynecological endoscopy procedures, can break during use. The FDA has received complaints of this breakage. Approximately 91 units are affected nationwide.

The ceramic tip on Olympus Resection Sheath Model A42011A (8 mm) can break during use. This gynecological surgical instrument is used in medical procedures, and a broken tip could create complications. No injuries have been reported, but the FDA is recalling all units as a precaution.

Olympus has recalled the Inner Sheath Model A2660, a medical device used in urological procedures. The ceramic tip of the resection sheath can break during use, which could affect the safety and effectiveness of the procedure.

The ceramic tip on Olympus Resection Sheath Model A22043T (28 Fr. with Deflecting Obturator) can break during use. This device is used in urologic surgical procedures. The FDA has identified 207 affected units across the US.

The ceramic tip on Olympus Resection Sheath model A22043A can break during use. This is a medical device used in urologic procedures. No injuries have been reported, but the broken tip could affect the device's function.

Olympus Corporation of the Americas is recalling the Resection Sheath 26 Fr. with Deflecting Obturator (Model A22042T), a medical device used in urologic procedures. The ceramic tip on this device can break during use, which may affect the procedure or patient safety.

Olympus has recalled its Resection Sheath 26 Fr. (Model A22042A) used in urologic procedures because the ceramic tip can break during use. The company has received complaints about this defect. All lots of this device are affected.

Olympus is recalling a urologic resection sheath because the ceramic tip can break during use. This affects Model No. A22041T units distributed nationwide. No injuries have been reported, but a broken tip could affect the device's function.

Olympus has recalled the Resection Sheath, 24 Fr (Model A22041A), a urologic medical device, because the ceramic tip can break during use. The company has received multiple complaints about this problem. About 3,484 units are affected nationwide.