Wolf, Henke Sass, Gmbh: Medical Device Recall in 2023 - (Recall #: Z-2642-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0

Product Classification:

Class II

Date Initiated: July 27, 2023

Date Posted: October 4, 2023

Recall Number: Z-2642-2023

Event ID: 92836

Reason for Recall:

Sterile barrier might be damaged compromising the sterility of the device.

Status: Ongoing

Product Quantity: 216,000

Code Information:

UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated