FDA-Device2026-09-02Class IIPACKAGING DEFECT
Medline surgical convenience kits recalled for potentially contaminated component
What this means
Medline surgical convenience kits used in open heart, valve, and endoscopic procedures contain a component that may be contaminated. The affected kits were distributed across multiple states. No injuries have been reported.
- Check if your facility has any of the listed Medline kit SKUs (CDS840393P, CDS840393Q, CDS980895W, CDS981551G, CDS982028W, DYNJ906903F, DYNJ906904C, DYNJ908362F, DYNJ910947, or DYNJ911488)
- Do not use affected kits; contact Medline or the FDA for instructions on return or disposal
- Check the lot numbers on your kits against the FDA notice to confirm whether your stock is affected
The agency's original wording
Hazard
Kits contain a potentially contaminated component which were recalled by the manufacturer
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Affected count
263 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3020-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline convenience kits recalled for sharp brush edges in Healthmark channel brushes
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