Medela ENFit ExSet Strl 60 2.0ml PV Recall
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Medela Inc is recalling 82,900 units of ENFit ExSet Strl 60 2.0ml PV 1ct EN devices due to potential incorrect connectors causing incompatibility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened Medela Inc initiated a voluntary recall because the product may contain incorrect connectors and will not attach or misconnect to ENFit connections, making it incompatible. This issue could lead to a slight delay in delivery of enteral nutritional fluids or oral medication.
Which Products Are Affected Brand Name: Medela. Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN. Model/Catalog Number: ENF060182LD / 101033086. Lot Number: 0000747253. Date of Manufacturing: 2026-01-16. Expiration Date: 2029-01-16. Carton GTIN: 20020451101358. Unit GTIN: 00020451101354. Quantity: 82,900 units. Distributed to AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA. Recall Number: Z-2645-2026. Classification: Class II.
What You Should Do Consumers in possession of the affected product should follow instructions provided in the firm's notification letter.
Why This Matters The recall affects a large quantity of enteral extension sets distributed across multiple U.S. states and involves a Class II classification for potential device incompatibility.
Source FDA recall number Z-2645-2026, report date 2026-07-08.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (1,163 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.