Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany
Lot Codes / Batch Numbers
UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Products Sold
UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany is recalling Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneo due to Sterile barrier might be damaged compromising the sterility of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterile barrier might be damaged compromising the sterility of the device.
Recommended Action
Per FDA guidance
Henke-Sass, Wolf GmbH notified the US Distributor on 7/24/24 via email and telecon. US Distributor notified their consignees (Distributors)via phone/ email on July 27, 2023. Letter states reason for recall, health risk and action to take: 1. Immediately remove any of these items with these lot numbers from active inventory. 2. Whether you do or do not have any of the items remaining in inventory, please complete the attached response form and return to atinfo@air-tite.com. 3. If you have inventory remaining, you will receive instructions and a return label once we have received your completed form. 4. If you have sent this product to another customer, forward this information, or collect the information and submit a response on their behalf. 5. If you have imported or distributed these products in Canada, please note that Health Canada has been notified and you may have specific additional obligations. If you have any questions or concerns, please contact us, atinfo@air-tite.com, (800) 231-7762.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026