Brand Name: Medela recallZ-2645-2026 · Medela Inc · initiated Jun 5, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medela Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2645-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Medela Inc
- Quantity
- 82900
- Product code
- FPA
- FDA submissions
- K895367
- 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.
Product description
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit Component: N/A
Code information (models, lots, serial numbers)
Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Enteral Feeding ENF060182LDMedela LLC · Set, Administration, Intravascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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