Quick Facts at a Glance
- Recall Date
- April 6, 2026
- Hazard Level
- HIGH
- Brand
- Fresenius Medical Care Holdings
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fresenius Medical Care Holdings
- Model numbers
- Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 6, 2026
Reported by FDA DRUG
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Fresenius Medical Care Holdings recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.. Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.. Classification: Class II. Quantity: 43,225 bags. Distribution: Nationwide in the USA
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.