FDA-Device2026-07-29Class IPROCESSING DEFECT
Medline medical procedure kits recalled for pain medication quality issues
What this means
Medline medical procedure kits used for knee and hip surgeries contain pain management medications with quality issues that could make them less effective. The affected kits were distributed to hospitals and surgical centers in Missouri, Colorado, and Illinois.
- Check your facility's inventory for the recalled kit SKUs: CDSOPT590T, CDSOPT590U, CDS983930J, CDS984556L, CDS984556M, and DYNJ905162Q
- Do not use kits with the lot numbers listed in the recall notice
- Contact Medline Industries for instructions on returning or replacing affected kits
- Review your procedure records if these kits were used, and consult with your medical team about any patients who may have been affected
The agency's original wording
Hazard
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: Mo, CO, IL
Affected count
318 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2765-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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