Greiner Bio-One North America, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0408-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Product Classification:

Class II

Date Initiated: August 8, 2025

Date Posted: November 5, 2025

Recall Number: Z-0408-2026

Event ID: 97457

Reason for Recall:

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

Status: Ongoing

Product Quantity: 504,000

Code Information:

UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated