All recalls8,424 total

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

Cyber vulnerability of BLE communication was found by CISA VDP program.

Cyber vulnerability of BLE communication was found by CISA VDP program.

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

Incorrect expiration date

Incorrect Product Formulation: product did not contain insulin as listed in the label.

Potential exposure of rodents and rodent activity in the 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.

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

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.

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.

Potential exposure of rodents and rodent activity in the distribution center.

Potential exposure of rodents and rodent activity in the distribution center.

Potential exposure of rodents and rodent activity in the distribution center.

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Potential exposure of rodents and rodent activity in the distribution center.

Potential exposure of rodents and rodent activity in the distribution center.

Potential Listeria Monocytogenes contamination

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.