Z-2645-2026Class II

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD /...

Name: Z-2645-2026 Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD /...
Creator: Medela Inc
Published: 2026-06-05
License: https://open.fda.gov/license/

Medela AG / initiated 2026-06-05 / Open, Classified

FDA source

Medela Inc began a recall of 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... on 2026-06-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2645-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-05
Posted: 2026-07-01
Recalling firm: Medela AG
Product: 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
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2645-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2645-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code FPA

K895367Class IIIntravenous Extension SetMedical Product Specialists / cleared 1989-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)