Brand Name: Medela Product Name: ENFit ExSet Strl 60 2 — Class II medical device recall Z-2645-2026
Ongoing recall by Medela Inc, reported 2026-07-08, distributed in AZ, CA, CO, FL, HI, IL, IN, MD…. May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatib
| Recall number | Z-2645-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medela Inc, Mchenry, IL, United States |
| Recall initiated | 2026-06-05 |
| Classified | 2026-07-01 |
| Reported by FDA | 2026-07-08 |
| Distributed | AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA |
| Quantity | 82,900 |
| UPC / GTIN / UDI-DI | 00020451101354, 20020451101358 |
| Lot numbers | 0000747253 |
| Model numbers | 101033086, ENF060182LD |
| Expiration dates | 2029-01-16 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2645-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.