Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medela

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medelasee related information
Date Initiated by FirmJune 05, 2026
Date PostedJuly 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2645-2026
Recall Event ID 99100
510(K)NumberK895367 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBrand 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 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
FEI Number 1419937
Recalling Firm/
Manufacturer		 Medela Inc
1101 Corporate Dr
Mchenry IL 60050-7006
For Additional Information Contact
815-578-2406
Manufacturer 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 Determined
Cause 2		Process change control
ActionOn 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 Commerce82900
DistributionUS distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
-
-