Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving unapproved design changes to surgical convenience kits. Class II recalls without reported illnesses are typically scored at 4 (Severe) under the rubric when they involve structural or design defects that pose a potential risk to patient safety during surgical use.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The affected kits include Craniotomy Pack-LF, Hybrid Pack, Laminectomy, Major Extremity, Neuro Cervical Pack, Neuro Spine Pack, Posterior Spine Pack-LF, and Spine Pack. A total of 113,843 kits have been distributed nationwide across the United States (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 to Barbados.
The firm identified unapproved design changes to the products that were made outside of the 510(k) clearance granted by the FDA. The affected products were not initially reported in FDA recall RES 98601.
Patients and healthcare providers using these kits should immediately discontinue use and contact Medline Industries, LP for instructions on product return or replacement. Additional lot numbers and UDI codes for the affected products are available from the FDA.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905
- Manufacturer
- Medline Industries, LP
- Hazard
- unapproved-design-change
- non-compliance-510k
Distribution
Distributed nationwide across the United States.
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