Accure Acne, Inc: Medical Device Recall in 2024 - (Recall #: Z-0778-2024)

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:

Accure Laser System, Model: PFMS00004

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 31, 2024

Recall Number: Z-0778-2024

Event ID: 93696

Reason for Recall:

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

Status: Ongoing

Product Quantity: 22

Code Information:

UDI-DI: 08059173392230, Serial Numbers: LAD0000-0004, LAD0000-0014, PROT01-0720, LAD0000-0012, LAD0000-0005, LAD2216-0623, LAD2356-0723, LAD0000-0003, PROTO07-1120, LAD2076-0623, LAD0000-0011, LAD0000-0008, LAD0000-0010, LAD2357-0723, LAD2075-0623, LAD2232-0723, LAD0000-0013, LAD0000-0009, LAD0000-0006, LAD0000-0001, PROT06-1120, LAD2507-0723

Distribution Pattern:

US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX

Voluntary or Mandated:

Voluntary: Firm initiated