The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to achieve its primary intended effects, the product is a drug, not a device. If it needs to be broken down (metabolized) by the animal’s body to work, the product is a drug, not a device.

Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices.

Recalls and Other Important Information:

The Center for Veterinary Medicine is sharing the following announcements from the FDA’s Center for Devices and Radiological Health about human medical device recalls that may potentially present significant risks to consumers or users of the product. CVM is sharing these recall announcements because these devices may be used in veterinary settings.

• UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
• Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions
• Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch
• Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes
• Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions
• Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays
• Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
• Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
  • Letter to Healthcare Providers - Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
• Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
  • Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
• Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire
• BD Announces Voluntary Recall on Intraosseous Products
• Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose
• Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)
• Medical Device Shortages During the COVID-19 Public Health Emergency
• FDA Statement on Quality Issues with Certain Cardinal Health Surgical Gowns and Packs 01-23-2020

You can find information on any recall monitored by FDA by viewing Enforcement Reports.

For more information:

How FDA Regulates Animal Devices
Animal Drugs Marketed as Animal Devices
Reporting Problems with Animal Devices