North Dakota recalls

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes used in neurological and angiography procedures contained design changes that were not reviewed or cleared by the FDA. These products were distributed nationwide and include multiple SKUs across neuro packs, angio packs, and related surgical kits.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were sold nationwide and include various surgical and procedural trays used in hospitals and medical facilities.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Dr G's Breast Pack, Lipo Supplement Pack-LF, and Plastic Pack products distributed nationwide.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain medical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not reviewed or approved by the FDA. These kits are used in cardiac catheterization, angiography, and other medical procedures. The firm has initiated a recall of affected lots.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Angiogram Pack-LF and Judkins Pack models distributed nationwide.

Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.

Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.

Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.

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.