Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Error with Tandem insulin pumps causes 700 adverse events, 59 injuries

A malfunctioning speaker is being blamed for the error code, which effectively pauses infusions on t:slim X2 insulin pumps. Tandem Diabetes Care has promised to release a software patch to improve the safety of the devices.

the words "FDA recall" on a board

FDA issues early alert on Baxter infusion pumps after 3 serious injuries

Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.

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FDA recalls breathing system filters after multiple injuries

Multiple lots of Draeger SafeStar and TwinStar filters—which are typically used during mechanical ventilation—are being removed from where they’re used and sold due to erroneous carbon dioxide readings.

Helene damage to bridge Baxter North Cove facility in North Carolina.

FDA confirms end to IV saline shortage caused by Hurricane Helene

Nearly 11 months after the hurricane flooded a Baxter manufacturing facility near Asheville, North Carolina, the resulting nationwide shortage of saline solution bags is officially over.

Assembly issue spurs FDA recall on manual resuscitators

A problem with the B/V filters on SunMed adult resuscitators can cause the devices to malfunction. Due to the high safety risk this poses to patients, the FDA has assigned this recall its most serious designation.

FDA recalls real-time glucose monitors after 56 injuries

Receivers on active glucose monitors manufactured by Dexcom are reportedly failing to send alerts when a patient’s blood sugar levels are dangerously high or low. There have been no deaths linked to the malfunction. 

the words "FDA recall" on a board

FDA issues recall on defective cranial drills after 10 injuries

The devices are manufactured by Integra LifeSciences. Due to a manufacturing error where inadequate welding has caused bits to get stuck in patients’ skulls, this recall has been designated as the most serious type.

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Trump teases 200% tariff on all pharmaceutical imports

After issuing a 50% tariff on copper imports this week, President Donald Trump said a massive levy on drugs could be announced “very soon.” The details are currently unknown.