FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for cannula components that may leak or break
What this means
Medline distributed surgical convenience kits containing cannula components that do not meet required safety standards. These components may leak or break during surgical use, potentially compromising the procedure.
- Check if your facility has any of the affected Medline surgical kits (multiple SKUs listed, including SPINAL CDS, CRANIOTOMY CDS, and others)
- Do not use affected kits in procedures
- Contact Medline Industries directly for instructions on returning or replacing the kits
- Check the lot numbers on any kits in your inventory against the recall notice
The agency's original wording
Hazard
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
6069 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU DYNJ67139D; 5) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AD; 6) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333K; 7) EXTREMITY-LF, Medline Product Number/SKU DYNJ905276F; 8) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AC; 9) SPINAL CDS, Medline Product Number/SKU CDS940087AL; 10) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697A; 11) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055; 12) CRANIOTOMY-RICHMOND, Medline Product Number/SKU CDS980929U; 13) ACB EXTRAS PACK-6211, Medline Product Number/SKU DYNJ49516; 14) SPINAL CDS, Medline Product Number/SKU CDS940087AK; 15) SPINAL CDS, Medline Product Number/SKU CDS940087AJ; 16) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AB; 17) SPINAL CDS, Medline Product Number/SKU CDS940087AI; 18) LAMINECTOMY PACK, Medline Product Number/SKU DYNJ17333J; 19) SPINAL CDS, Medline Product Number/SKU CDS940087AG; 20) CRANIOTOMY CDS, Medline Product Number/SKU CDS780025AA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0179-2027More Medline recalls
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline sterile C-section surgical drape recalled for difficult removal and skin adhesive residue
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline surgical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline tubal ligation surgical kit recalled for difficult removal and skin adhesive residue
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