North Dakota recalls

Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

Potential undeclared allergen ingredient (Wheat)

Potential undeclared allergen ingredient (Wheat)

elevated levels of chloramphenicol in frozen shrimp

Foreign material

elevated levels of aflatoxin

Presence of Particulate Matter.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.