MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-1450-2024)

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:

Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

Product Classification:

Class II

Date Initiated: February 23, 2024

Date Posted: April 10, 2024

Recall Number: Z-1450-2024

Event ID: 94136

Reason for Recall:

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Status: Ongoing

Product Quantity: 270 units

Code Information:

a) HUD112ST, UDI/DI 50653160068288 (case) 00653160068283 (each), Lot Numbers: 2023032190; b) HUD12ST, UDI/DI 00653160288810 (case) 10653160288817 (each), Lot Numbers: 2023061690, 2023112990; c) HUD56ST, UDI/DI 50653160068257 (case) 00653160068252 (each), Lot Numbers: 2023112190; d) HUD910ST, UDI/DI 50653160068271 (case) 00653160068276 (each), Lot Numbers: 2023031390; e) I68920, UDI/DI 00653160351323 (case) 10653160351320 (each), Lot Numbers: 2023110290; f) I68930, UDI/DI 00653160351293 (case) 10653160351290 (each), Lot Numbers: 2023110990

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Voluntary or Mandated:

Voluntary: Firm initiated