South Dakota recalls

During manufacturing, Medtronic discovered that tubing was installed backwards on some Octopus 4 Tissue Stabilizer devices: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This affects 590 units with specific serial numbers distributed nationwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution AS Tissue Stabilizer units where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite the correct design. This incorrect assembly could affect proper operation during surgical use. The issue affects 288 units distributed worldwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.

Certain lots of Dexcom G7 continuous glucose monitoring sensors that were designated for destruction were stolen and later sold to pharmacies and distributors without authorization. Two affected lots have different risks: one was not properly sterilized and poses an infection risk, and the other may not provide accurate readings or detect dangerous blood sugar levels.

Surgify Medical's Halo 5.4 mm burr (Model 54.140.SHD.U1) used in spinal surgery may break during the procedure. This could leave fragments inside the surgical site or require additional intervention. The issue affects all lots distributed in the US until an updated instruction document is provided.

Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during use. The company has identified this risk and is notifying healthcare facilities.

Surgify Medical's Halo 5.4 mm burr (model 54.125.NVG.U1) may break during bi-portal endoscopic spinal surgery. The company has identified this risk and is working to update instructions for use. No injuries have been reported.

Surgify Medical's Halo 5.4 mm burr (Model 54.125.NVG.H1) may break during bi-portal endoscopic spinal surgery. The device has been distributed across multiple U.S. states. No injuries have been reported.

Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during the procedure. The company has identified this risk and is recalling affected units.

Surgify Medical's Halo 5.4 mm surgical burr (Model 54.085.SHD.H1) may break during bi-portal endoscopic spinal surgery. The risk affects all product lots distributed in the US until updated instructions are implemented.

Surgify Medical's Halo 5.4 mm burr (Model 54.070.NVG.U1) may break during bi-portal endoscopic spinal surgery (BESS). The risk affects all lots distributed in the U.S. until updated instructions are provided.

Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during the procedure. This affects spinal surgery burrs distributed across the US.

Surgify Medical's Halo 5.4 mm extendable burr (Model 54.000.SEE.U1) may break during bi-portal endoscopic spinal surgery (BESS). The defect affects 8 units distributed across the US. No injuries have been reported.

Surgify Medical's Halo 5.4 mm extendable burr may break during bi-portal endoscopic spinal surgery (BESS). This surgical instrument is used by spine surgeons, and burr breakage during the procedure could complicate the operation. No injuries have been reported.

Surgify Medical's Halo 40 mm burr tool, used in minimally invasive spinal surgery, may break during the procedure. This could interrupt surgery or leave fragments in the surgical site. The recall affects all units until the manufacturer updates instructions for use.

Surgify Medical's Halo 4.0 mm burr (Model 40.125.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur while the burr is in use, potentially affecting the procedure.

Surgify Medical's Halo 4.0 mm burr, used in spinal surgery, may break during the procedure. The affected model is 40.070.NVG.U1. This issue affects all lots currently distributed until the manufacturer updates its instructions.

Surgify Medical's Halo 4.0 mm short burr (model 40.070.NVG.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur during the procedure and compromise the surgical outcome. This affects all lots distributed in the US until updated instructions are implemented.

Surgify Medical's Halo 4.0 mm extendable burr, used in spinal surgery, may break during the procedure. The breakage could occur during bi-portal endoscopic spinal surgery (BESS). This affects all lots until the manufacturer updates the product instructions.

Surgify Medical's Halo 4.0 mm extendable burr (Model 40.000.SEE.H1) may break during bi-portal endoscopic spinal surgery (BESS). The breakage could occur during the procedure and potentially complicate the surgery. This affects 112 units distributed across several US states.

Surgify Medical's Halo 3.0 mm burr (Model 30.125.NVG.U2) may break during bi-portal endoscopic spinal surgery (BESS). The issue affects all lots until updated instructions are implemented. No injuries have been reported.

Surgify Medical's Halo 3.0 mm burr (Model 30.070.NVG.U2) may break during bi-portal endoscopic spinal surgery (BESS). The risk affects all lots distributed in the US until updated instructions are provided.

Surgify Medical's Halo 3.0 mm extendable burr (Model 30.000.SEE.U2) may break during bi-portal endoscopic spinal surgery. The breakage could occur during the procedure. This affects 15 units distributed across several US states.

A software issue in the Thuvera Laser Console (Software Version 2.2) causes the device to display a false error code 5018. This anomaly may lead clinicians to misinterpret the device status during operation.

GE Healthcare's AW Server 3.2 ext.6.5 has a software issue that can cause the system to display a previous patient's medical images instead of the correct patient's images when launching certain applications. There is no warning or error message when this happens. If a radiologist or clinician does not notice the error, they could misread images, make wrong diagnoses, or recommend incorrect treatment.

Stryker Neurovascular's INZONE Detachment System devices may experience premature battery drain, causing them to fail to power on, display faint indicators, or be unable to detach an embolization coil as intended. If a device fails during a procedure, medical staff may need to use an alternative technique to complete the intervention.

Acumed Hexalob Screws used in wrist fixation systems may break during use due to a manufacturing error. The affected screws come in various sizes (2.7mm and 3.0mm) and have been distributed nationwide. No injuries have been reported.

Zimmer identified a defect in the Off-Axis Alliance Glenoid Reamer Guide where plastic components can catch and break during the reaming procedure. Five complaints of this issue have been reported. The affected surgical instrument was distributed nationwide, with 13 units involved.

Zimmer, Inc. is recalling a surgical guide used during shoulder implant procedures. Five reports have identified that the plastic guide can catch and break during the reaming step of surgery, potentially affecting the procedure.

The plastic guide in Zimmer's Off-Axis Comprehensive Shoulder System reamer tool can catch during the reaming procedure, causing it to break. The FDA received five complaints about this issue. No injuries have been reported.