Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Softw
FDA device recall Z-2645-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Medela Inc
- Reason for recall
- May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
- Action taken
- On June 5, 2026, the firm notified customers via letters titled "URGENT Medical Device Recall." Customers were instructed to quarantine affected product lots, dispose of products, and complete and return a customer response form. Upon receipt of the completed response form, Medela will contact the customer to replace product.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 82900
- Distribution
- US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
- Date initiated
- 2026-06-05
- Date posted
- 2026-07-01
- Location
- Mchenry, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVENOUS EXTENSION SET (K895367) | Medical Product Specialists | 1989-10-06 |