Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in surgical procedures. Unapproved design changes to surgical instruments represent a significant risk of harm in a healthcare setting, meeting the Severe classification criterion.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The affected kits include bariatric, gynecology laparotomy, laparoscopy, major plus, minimally invasive, percutaneous, and robotic surgical packs distributed nationwide across the United States and Barbados.
The manufacturer identified unapproved design changes to these products that fall outside of the FDA 510(k) clearance. The products were not initially reported in FDA recall number RES 98601.
Approximately 113,843 kits have been distributed. A comprehensive list of affected product codes and lot numbers is available from the FDA, and healthcare facilities that received these kits should verify the UDI-DI numbers and lot codes against the FDA's official recall notice.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR…
- Manufacturer
- Medline Industries, LP
- Affected units
- 113,843
Distribution
Part of a larger recall action
This product is one of 16 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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