HIGHFDA DEVICE

Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4)...

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.

Medline Industries, LPHealth & Personal CareMedical Devices1) ECVC8520UDI-DI: 10653160375104(each)00653160375107(case)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 21, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 21, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Model numbers
1) ECVC8520, UDI-DI: 10653160375104(each), 00653160375107(case), Lot Number: 2026031790, 2) CVI4880B, UDI-DI: 10653160377191(each), 00653160377194(case), Lot Number: 2026021190 +11 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 21, 2026

  2. Reported by FDA DEVICE

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for Medline Industries, LP recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Full Description

Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; 12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980; 13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; 14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A; 15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A; 16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640; 17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B; 18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605; 19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330; 20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; 21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110; 22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A; 23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B; 24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC; 25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180; 27) NO CATH DIALYSIS KIT, Model Number: ECVC8595; 28) SOFT TISSUE TRAY, Model Number: DYNDA1954A; 30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A; 31) LACERATION TRAY, Model Number: SUT10520; 32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB; 33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B; 34) BIOPSY TRAY, Model Number: MNS7065A; 35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85; 36) A LINE TRAY, Model Number: ART690; 37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490; 38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633; 39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A; 40) BIOPSY PACK, Model Number: DYNDH1135B; 41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; 42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485; 43) ULTRA SOUND TRAY, Model Number: CVI190; 44) BASIC BIOPSY TRAY, Model Number: SPEC0051; 45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB; 46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A; 47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; 48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406; 49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632; 50) I & D KIT, Model Number: ID1135A; 51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637; 52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080; 53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; 54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331; 55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA; 56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B; 57) A LINE KIT, 20G, Model Number: ART1303; 58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; 59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C; 60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616; 61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A; 62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B; 63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475; 64) CVC BUNDLE KIT, Model Number: ECVC1700; 65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C; 66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950; 67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360; 68) PLASTICS SUTURING SET, Model Number: SUT4065; 69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465; 70) ARTHROGRAM TRAY, M. 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 II. Quantity: 48075 kits. Distribution: US Nationwide distribution.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

Want to Know First?

Get instant alerts for recalls that affect you. Free forever.

Product Classification

Product Details

Model Numbers
1) ECVC8520
UDI-DI: 10653160375104(each)
00653160375107(case)
Lot Number: 2026031790
2) CVI4880B
+14 more
Affected States
ALL
Report Date
July 8, 2026
Recall Status
ACTIVE

Related Recalls