- Recalling firm
- Medline Industries, LP
- Reason for recall
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
- Affected products (lot / model / serial)
- Medline kit number/SKU CDS983529O, UDI/DI 10198459603464 (each) 40198459603465 (case), Lot Number CDS983529O; Medline kit number/SKU CDS983529O, UDI/DI 10198459603464 (each) 40198459603465 (case), Lot Number CDS983529O; Medline kit number/SKU DYNJ52432M, UDI/DI 10198459508035 (each) 40198459508036 (case), Lot Number DYNJ52432M; Medline kit number/SKU DYNJ52432M, UDI/DI 10198459508035 (each) 40198459508036 (case), Lot Number DYNJ52432M; Medline kit number/SKU DYNJ60646A, UDI/DI 10198459363658 (each) 40198459363659 (case), Lot Number DYNJ60646A; Medline kit number/SKU DYNJ60646A, UDI/DI 10198459363658 (each) 40198459363659 (case), Lot Number DYNJ60646A; Medline kit number/SKU DYNJ906291F, UDI/DI 10198459419591 (each) 40198459419592 (case), Lot Number DYNJ906291F; Medline kit number/SKU DYNJ906291F, UDI/DI 10198459419591 (each) 40198459419592 (case), Lot Number DYNJ906291F.
- Units affected
- 545 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0277-2027
- Recall initiated
- September 9, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99960
- Last updated on HTM Vibe
- November 3, 2026
