HIGHFDA DEVICE

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

RemelHealth & Personal CareMedical DevicesR01460 - GC Agar Base (100mm) 10/PK UDI-DI 848838001796 Lots 338950 356898 359912 365679 371863 376799 382136 384712 393488 396333 402458R04030 - GC Agar Base (150mm) 10/PK UDI-DI 848838004469 Lots 336864 345992 348754 359925 367829 374235 376786 381488 385224 391312 393478

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 3, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 3, 2026
Hazard Level
HIGH
Brand
Remel
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
Remel
Model numbers
R01460 - GC Agar Base (100mm) 10/PK UDI-DI 848838001796 Lots 338950 356898 359912 365679 371863 376799 382136 384712 393488 396333 402458, R04030 - GC Agar Base (150mm) 10/PK UDI-DI 848838004469 Lots 336864 345992 348754 359925 367829 374235 376786 381488 385224 391312 393478
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 3, 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

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

What You Should Do

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

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Full Description

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460. Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae.. Classification: Class II. Quantity: 1573. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.

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

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Product Classification

Product Details

Brand
Model Numbers
R01460 - GC Agar Base (100mm) 10/PK UDI-DI 848838001796 Lots 338950 356898 359912 365679 371863 376799 382136 384712 393488 396333 402458
R04030 - GC Agar Base (150mm) 10/PK UDI-DI 848838004469 Lots 336864 345992 348754 359925 367829 374235 376786 381488 385224 391312 393478
Affected States
ALL
Report Date
July 8, 2026
Recall Status
ACTIVE