Remel, Inc: Medical Device Recall in 2024 - (Recall #: Z-0266-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

Product Classification:

Class II

Date Initiated: September 20, 2024

Date Posted: November 6, 2024

Recall Number: Z-0266-2025

Event ID: 95458

Reason for Recall:

A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

Status: Ongoing

Product Quantity: 29 kits

Code Information:

Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

Distribution Pattern:

Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated