Medline Industries, Lp: Kit, Surgical Instrument, Disposable
Recall Summary Medline Industries is recalling Suturing Sets (Model SUT13710) that contain Lidocaine Ampules due to quality issues identified during an FDA inspection of the manufacturer. The kits were distributed nationwide across all U.S. states and Washington, D.C. This is a Class I recall, the most serious classification.
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
- Reason
- The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8836b699-e44d-498f-9f16-b5e4d61d7799