FDA-Device2026-07-01Class IIPROCESSING DEFECT
Medline convenience kits with 10mL syringes recalled for unapproved design changes
Medline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. The changes were made outside the scope of the FDA clearance originally granted for these products.
- Check if you have Medline kit SAMP0551 (UDI-DI 10195327268503) with lot numbers 22JBG593 or 22JBJ361.
- Do not use affected kits until you receive further guidance from Medline or your healthcare facility.
- Contact Medline Industries or your supplier for instructions on return or replacement.
Hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
Affected count
113,843 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2026More Medline recalls
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- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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