REPLIGEN CORPORATION: Medical Device Recall in 2026 - (Recall #: Z-1024-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Product Classification:

Class II

Date Initiated: December 10, 2025

Date Posted: January 21, 2026

Recall Number: Z-1024-2026

Event ID: 98260

Reason for Recall:

Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.

Status: Ongoing

Product Quantity: 33

Code Information:

PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Distribution Pattern:

U.S.

Voluntary or Mandated:

FDA Mandated