CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Medline Convenience Kits: Suturing SET recalled by Medline Industries
Medline Industries is recalling Medline Convenience Kits: Suturing SET, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2540-2026
- FDA event ID
- 99162
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 29 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 29 Jun 2026 | Classified by FDA | +39 days |
| 8 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Medline Convenience Kits: Suturing SET recalled?
Yes. Medline Industries recalled Medline Convenience Kits: Suturing SET on 21 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2540-2026.
Why was it recalled?
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.
Which lots are affected?
1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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