Two separate FDA recalls issued in early July 2026 affect insulin pump users and patients undergoing surgery or IV procedures. The Omnipod recall involves a potential tubing tear that could prevent insulin delivery, while the BD ChloraPrep recall addresses possible fungal contamination in skin-prep applicators used before medical procedures. Both recalls require immediate action from affected patients and their healthcare providers.

What's Wrong With Omnipod Insulin Pumps?

The FDA issued a Class I recall for certain Insulet Omnipod pods on July 2, 2026, following an Early Alert issued on June 4, 2026. A Class I recall is the most serious type, meaning the FDA believes the product could cause serious harm or death if used. The problem: some pods from specific lots may have a small tear in the tubing (called a cannula) just above the skin, between the pod and where the cannula enters the body.

When this tear occurs, insulin may leak outside the pod instead of being delivered into the body. This can lead to insulin under-delivery, causing blood glucose to rise unexpectedly. In severe cases, prolonged high blood glucose can trigger diabetic ketoacidosis (DKA), a medical emergency. As of May 20, 2026, Insulet reported 24 serious injuries and no deaths associated with this issue.

The recall affects three Omnipod systems: Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and Omnipod Insulin Management System (Omnipod Eros).

How Can You Tell If Your Omnipod Is Affected?

The FDA warns that the problem may be difficult to detect. Some people may notice wetness on the skin, pod adhesive, or detect an insulin smell, but in many cases it may go unnoticed. The FDA specifically cautions against relying only on pod alerts to decide whether insulin delivery is working.

To check if your pods are affected, locate the lot number on the pod tray lid, pod box, or the pod itself, then compare it to the affected-lot information on the FDA website. All pods within a single box will be from the same lot, so if that lot is affected, do not use any pods in that box.

Steps to Take If You Use Omnipod

• Check Your Lot Number: Locate the lot number on your pod tray lid, pod box, or the pod itself and compare it to the FDA's list of affected lots on the agency's website.
• Stop Using Affected Pods: Do not use any pods from affected lots. If you're currently using a pod from an affected lot, change your pod immediately to resume insulin delivery and confirm the replacement pod is not from an affected lot.
• Request Replacements: Follow Insulet's customer instructions to request replacement pods. If your pod supply is depleted, contact your healthcare provider about alternative insulin delivery methods while replacements are provided.
• Monitor Blood Glucose Closely: Watch for unexpectedly high glucose readings and follow your clinician's plan for checking ketones and when to seek urgent care.
• Contact Insulet Support: Call Insulet Product Support at the 24/7 number listed on the FDA website if you have questions or quality concerns.
• Always Check Expiration Dates: Before using any pod, verify the expiration date, as expired pods may not work as intended.

If you suspect an affected pod contributed to insulin under-delivery, watch for signs of ketones and diabetic ketoacidosis. The American Diabetes Association advises calling your doctor if ketones are elevated and going to the emergency room or calling 911 immediately if you experience severe symptoms such as vomiting, trouble drinking, confusion, or heavy breathing, or if ketones stay high or get worse.

What About the BD ChloraPrep Recall?

If you or a family member recently had surgery or had an intravenous (IV) line or catheter placed, a separate FDA recall may be relevant. BD is recalling specific lots of skin-prep applicators used before procedures because of potential contamination with Aspergillus penicillioides, a type of fungus. The recall applies to ChloraPrep Clear (single sterile applicators, 1 mL) and FREPP Clear (single sterile applicators, 1.5 mL).

The FDA posted the recall notice on June 8, 2026, following BD's announcement on June 6, 2026. The concern is that contamination with Aspergillus penicillioides may lead to serious systemic infection, including sepsis, if the fungus is introduced during an invasive procedure. If contamination enters the bloodstream during intravascular catheter placement, clinicians may need to evaluate whether catheter removal or other interventions are necessary. At a surgical site, infection can require additional medical care and may involve antifungal treatment in confirmed cases.

Aspergillosis risk is generally higher in people with weakened immune systems and certain lung conditions. The Centers for Disease Control and Prevention (CDC) notes that most people who breathe in Aspergillus spores do not get sick, but higher-risk patients are more likely to develop illness.

Who Should Be Concerned About the BD ChloraPrep Recall?

The recall is lot-specific, and facilities may have different inventory at different times. If you recently had a procedure, it's worth asking your care team whether any recalled lots were used. This is especially important if you are immunocompromised or have a weakened immune system.

• IV or Intravascular Catheter Placement: If you recently had an IV line or central line placed, contact the facility and ask whether any recalled lots of ChloraPrep or FREPP were used during your procedure.
• Surgery or Other Invasive Procedures: If you had any surgical procedure or other procedure that creates an entry point for infection, have your timeline ready and be prepared to share the approximate procedure date and type of procedure so staff can check lot records.
• Immunocompromised Status: If you have a weakened immune system, it is especially reasonable to ask your care facility for an update about whether any recalled lots were used during your procedure.

What Symptoms Should Prompt Urgent Care?

Symptoms of aspergillosis can vary depending on the type of infection and where it spreads. The CDC describes invasive aspergillosis as serious and lists possible symptoms including fever, chest pain, cough, coughing up blood, and shortness of breath. Seek urgent medical evaluation, or emergency care depending on severity, if you develop severe or rapidly worsening symptoms after a procedure, particularly if you are high-risk. Because symptoms can overlap with many other conditions, the key point is to get prompt assessment so clinicians can evaluate you.

Also contact your care team for guidance if you are concerned that a recalled lot could have been used during your procedure.

How to Report Problems to the FDA

• MedWatch Program: Consumers and healthcare professionals may report adverse reactions or quality problems experienced with recalled devices to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Provide Specific Details: When reporting, include details that help identify the device, such as the product type and relevant lot information, timing of symptoms, and what your glucose or ketone readings showed.
• Document Your Experience: If you suspect an affected product contributed to a health problem, document what happened so you can provide accurate information to your healthcare provider and the FDA.

Both recalls underscore the importance of staying informed about product safety and maintaining close communication with your healthcare team. If you use Omnipod insulin pumps or recently had a procedure using BD skin-prep products, taking these steps now can help protect your health.