Mentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error
Mentor Texas LP is recalling a single lot of expired 10cc Luer Lok syringes distributed to California, Florida, and Pennsylvania due to a distribution system control failure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with compromised sterility assurance due to expiration. Although no illnesses or injuries have been reported, expired syringes present a direct risk of harm through loss of sterility and device integrity, which meets the High severity threshold for risk-of-harm products.
Plain-English summary
Mentor Texas LP is recalling lot 8298877 of SYRINGE LUER LOK 10CC-200/BOX (BD Product Code 302995, Mentor Product Code B9604). A total of 1,401 syringes were affected by this recall. The syringes were distributed with an expiration date error due to a failure in the company's distribution system controls.
The syringes were distributed to healthcare facilities in California, Florida, and Pennsylvania. Expired syringes may not maintain their sterility and functional integrity, potentially compromising patient safety if used.
Patients and healthcare providers who have received or possess syringes from this lot should stop use immediately. Healthcare facilities should quarantine remaining stock and contact Mentor Texas LP or their distributor for return or replacement instructions. The recall number is Z-2614-2026.
The recalled product
- Product
- SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- Manufacturer
- Mentor Texas LP
- Category
- Medical Device — Syringes
- Affected units
- 1,401
Distribution
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